Official source
Verified ClaimWatch records sourced from U.S. Food and Drug Administration, including recalls, safety alerts, refunds, and consumer instructions.
Failed Dissolution Specifications Product details: Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01
Product may be contaminated with Salmonella. Product details: 1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood...
Potential for Salmonella Product details: Dairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box
Product may be contaminated with Salmonella Product details: Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case
Product tested positive for Salmonella Product details: Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags
Products were made with recalled California Dairies milk powder due to Salmonella. Product details: White Cheddar Seasoning packed in the following sizes and configurations: 1. Net Wt. 1.2...
Potential for Salmonella Product details: Dairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified...
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified...
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified...
Potential Salmonella Javiana contamination Product details: Sirna & Sons Produce PEPPER JALAPENO BREAK 1LB, repackaged into 1 lb. plastic bags, Product Number: 55255, Packed by Sirna &...
Product may be contaminated with Salmonella. Product details: bettergoods brand Pistachio Nut Butter, NET WT 6.7oz (190g), UPC 194346207961
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella. Product details: Whole Foods Medium Pico de Gallo Guacamole Dip, Keep Refrigerated. Packed...
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella. Product details: Whole Foods Spicy Guacamole Dip, Keep Refrigerated. Packed in various sized...
Product tested positive for undeclared milk. Product details: Frankie's Organic Plant-Based Puffs Vegan Cheddar, NET WT. 4 oz. (113 g). Product is packaged into flexible plastic bag, UPC...
Discoloration: consumer complaints received for discolored tablets Product details: amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com...
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40 Product details: Bombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO...
Possible Salmonella in Moringa Leaf Powder product. Product details: Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bottle....
Product may be contaminated with Salmonella Typhimurium Product details: MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE CAPSULE, 100% PURE, 350 MG PER...
Potential contamination with Salmonella Product details: Trafa Pharmaceuticals Inc. brand ORGANIC MORINGA LEAF POWDER; NET WEIGHT: 15 KGS; packaged in brown paper bags with a white label
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential...
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the...
Moringa Powder ingredient positive for salmonella Product details: Organic Moringa Powder; 15kg/bag (bulk); Product code: GJ96
Contaminated with Salmonella Product details: 1. TNVitamins 100% Organic Moringa Capsules 1,200 mg 2. TNVitamins 100% Organic Moringa Powder 96 grams
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination Product details: Alfredo Sauce, 3 lb. 7 oz., packaged in a sealed poly bag...
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement. Product details: Zarlengo's Double Dark Chocolate Gelato packaged in 1 Gallon bucket/pail...
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement. Product details: Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6...
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement. Product details: Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16...
Contamination with Listeria monocytogenes Product details: Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods...
Undeclared milk, cheese declared Product details: QUESO PALMITA. Generic Name: Pastel de Queso (Cheese Pie). Intended use: Human consumption. Condition: Frozen. Shelf life or expected...
Undeclared soy allergen: soybean oil and soy lecithin Product details: Saint Francis Apizza Frozen Pepperoni Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed...
Soy was not declared in the Contains statement. Product details: Chocolate Chip Cookies packaged in a cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron,...
Product contains undeclared Sildenafil and Tadalafil. Product details: X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by...
Seeds may have been contaminated with E.coli Product details: LEASA Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 6 OZ. (170g); Grown & Packaged by:...
Bean Dip Trays contains recalled Peperoncini (pepper) which was recalled due to pest issue. Product details: WinCo Foods Salsa Bean Dip Express Tray is packaged in a foil bottom container...
Egg was not declared in the Contains statement. Product details: Croissant; packaged in cardboard box; Ingredients: King Midas Special (Wheat flour, niacin, reduced iron, thiamine...
Undeclared soy allergen: soybean oil and soy lecithin Product details: Saint Francis Apizza Frozen Cheese Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic,...
Potential contamination with foreign objects: mice. Product details: Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G.L. MEZZETTA, INC., AMERICAN CANYON, NAPA VALLEY, CA 94503...
Potential contamination due to E. coli O26:H11. Product details: SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR NET WT. 40 LBS Item 6516
Undeclared Milk. Product details: Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons per case. UPC 850041392103. Paperboard carton...
Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella contamination. Product details: Berlin Seeds Alfalfa Sprouting Seeds, packaged in 1/4 lb.,...
Undeclared soy allergen: soybean oil and soy lecithin Product details: Saint Francis Apizza Frozen Supreme Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed plastic,...
Product contains undeclared Sildenafil and Tadalafil. Product details: biQ-FEL, 16.9 fl oz (500 mL), 17 servings per bottle, Manufactured by ALMENAT SAS AV 39 OESTE No 10 OESTE-18 CALI...
Product contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement. Product details: Lemon Blueberry Loaf packaged in a...
Seeds may have been contaminated with E. coli Product details: LEASA Living Alfalfa Sprouts; packaged in plastic clamshell containers; KEEP REFRIGERATED; NET WT. 4 OZ. (113g); Grown &...
Lack of Assurance of Sterility Product details: Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017,...
Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Product details: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage...
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Product details: TIRZEPATIDE/CYANOCOBALAMIN...
Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Product details: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use...
Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Product details: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use...
Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Product details: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use...
Lack of Assurance of Sterility Product details: Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles,...
Failed Impurities/Degradation Specifications Product details: Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only,...
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Product details: Tri-MIX...
Presence of particulate matter. Product details: IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only,...
Foreign object: May contain pieces of metal Product details: Stewarts Shops Vanilla Heavenly Medley 1/2 Gallon (1.89 L), UPC Codes: 0 82086 44371 1
Undeclared soy. Product details: J. HIGGS Loaded Bacon & Cheddar Potato Chips, NET WT 7.75 OZ (219.7g) bag, UPC 051933316454. Sold as 13 (7.75oz) bags per case.
May contain undeclared aspartame. Product details: Pur Aqua Sparkling Frost Cherry Limeade 17 oz., UPC: 4099100167023
Products may be contaminated with Listeria monocytogenes. Product details: Made Fresh brand Black Bean and Corn Salad; 5lb white plastic tub
defective packaging; packaging can rupture/explode during cooking. Product details: Made From Plants; Daring; Plant Steak Bites; Ready in 4 Mins Microwaveable Pouch; UPC: 86001124319
Foreign object: May contain pieces of metal Product details: Stewarts Shops Vanilla chocolate Strawberry Ice Cream 1/2 gallon (1.89 L), UPC: 0 82086 44377 3
Undeclared colors (FD&C Blue No. 1 and FD&C Yellow No. 5) Product details: Holsum Spinach Flour Tortillas Large, 8 count (20 oz.) UPC: 810023430629
Undeclared Lobster Product details: Deano's Pasta; Pear and Pecorino Triangoli Ravioli, 1lb.; Ingredients: Dough: Semolina (Wheat, Niacin, Thiamine, Mononitrate, Riboflavin, Folic Acid),...
Lack of process control Product details: Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Presence of Foreign Tablets/Capsules Product details: Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ...
Presence of Foreign Tablets/Capsules Product details: Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217....
Failed Impurities/Degradation Specifications. Product details: Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd.,...
Lack of assurance of sterility. Product details: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX...
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead...
Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered...
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead...
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use....
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. Product details: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro...
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events...
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial...
Discrepancy in the shelf-life of a component Product details: Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in...
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use....
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use....
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If...
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than...
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was...
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in...
Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Product details: Todd's Seeds Salad Sprouting Mixture -...
Product contains elevated levels of lead. Product details: Lior brand Cinnamon Ground Seasoning; 90g transparent plastic container; UPC 794711005484.
Product contains garlic essential oil not approved for culinary use Product details: Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil, packaged in 3.4 fl oz (100mL), 8.5 fl oz...
Product may contain undeclared sugar. Product details: 7up Tropical beverage, shelf stable, 12oz can in a 12pk wrap, labeled as 7 up Tropical Beverage containing cans that are labeled as...
Undeclared soy allergen: soybean oil and soy lecithin Product details: Saint Francis Apizza Frozen Mushroom & Onion Pizza, Net Weight: 17 oz. (482g), packaged individually in vacuum-sealed...
Undeclared Yellow No. 6 and/or Yellow No. 5 Product details: 28 oz. Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero.
Staphylococcus aureus detected in product. Product details: Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product is packaged in sealable & flexible gold,...
The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, it is not included in the allergen Contains...
Lack of Assurance of Sterility Product details: Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ Fast Acting Formula) Product size: 0.5 fl oz (15 mL); a) Best...
Lack of Assurance of Sterility: Related to processing equipment used in compounded product. Product details: Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use...
Lack of Assurance of Sterility Product details: Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC 27513, NDC...
Failed Content Uniformity Specifications Product details: Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod#...
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product. Product details: Tri-MIX...
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization,...
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard...
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or...
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. Product...
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front...
Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Product details: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF...
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the...
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar...
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard...
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard...
Lack of 510(k) clearance. Product details: Glypto Device, Glypto Cryo Machine;
Product may be potentially contaminated with a lubricant used during the manufacturing process. Product details: ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard...
Product may be potentially contaminated with a lubricant used during the manufacturing process. Product details: ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;
Sprouts may be contaminated with STEC E. coli and/or Salmonella. Product details: Everything Sprouts Crunchy Protein Sprout Mix, containing Alfalfa Fenugreek, Cabbage, Mung, Adzuki,...
Potential contamination with Salmonella. Product details: Tomato Salsa Fresca. Ingredients: Tomatoes, Yellow Onion, Red Onion, Cilantro, Jalapeno Pepper, Garlic, Salt, Ground Cumin, Lemon...
Undeclared Egg Allergen Product details: Fromagerie Coop de Mean Cabricharme and Belgium Cabricharme Shelf life: 30 days, all dates through and including 10/7/2026 Packaging: Plastic...
Potential contamination with pesticides. Product details: American Ginsengs. PRODUCT OF WISCONSIN. NET WT: 4 oz. NET WT. 8 oz.
Potential Wheat Kernel contamination. Product details: Light Brown Sugar, Packaged in he follow configurations: 1. United, Net Wt. 50 lbs., (22.68kg). Item Number 810051. Distributed By:...
Inaccurate Nutrition Facts information listed on product Product details: Almond Joy Ice Cream Bar, 2.0 fl. oz. ice cream bars, paper cartons containing individually wrapped ice cream bars...
Potential Wheat Kernel contamination. Product details: Powdered Sugar, Packaged in the following configurations: 1. United 6X, Net Wt. 50 lbs. (22.68kg), Item Number 810087. UPC 7...
Product may contain foreign material: small stones and other hard objects. Product details: So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert. 16 oz paper...
Salmonella Product details: Evergreen Fresh Sprouts LLC, Broccoli Sprouts, packaged in clear plastic zip lock bag, net wt. 4oz, UPC 8 38796 00105 1. Firm distributed cases (6/4oz. bags per...
Potential Listeria contamination from dripping condensation in cooler. Product details: Pecorino Toscano D.O.P. STAGIONATO cheese wheels. Product of Italy. Each cheese wheel is...
Lack of Assurance of Sterility Product details: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles,...
Lack of Assurance of Sterility Product details: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL)...
Lack of Assurance of Sterility Product details: Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz...
Lack of Assurance of Sterility Product details: Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by...
Lack of Assurance of Sterility Product details: Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by:...
Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Product details: Todd's Seeds Broccoli & Friends Sprouting...
Potential Salmonella contamination. Product details: Coco G's Courmet Flaming Cheddar Hots, Spicy Cheddar Cheese Popcorn. Packaged in the following sized plastic bags: 1. 2.5 oz (81g), UPC...
This recall was initiated due to potential Salmonella contamination in diced jalape¿no received from the supplier Product details: Salata Salad Kitchen Jalapen¿o Avocado Dressing. Keep...
Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Product details: Todd's Seeds Variety Pack of Sprouting...
Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Product details: Todd's Seeds Alfalfa & Mung Bundle (1lb...
Undeclared Yellow 5 & 6, Red 3, and Blue 1 Product details: Khazana The Treasure Spice Magic Fennel Candy, 5 lbs., Poly Plastic Bag, 4 per case
Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Product details: Todd's Seeds Sprouting Seed Mix -...
Undeclared allergen ingredient (fish) Product details: Cloud Cafe branded Collagen Milk; Strawberry Milk Zero; Caffeine Free; 10pc/box
Undeclared shellfish (crab shell): source of ingredient Glucosamine sulfate Product details: Organiccs Absolutely Pure, Type-1 Hydrolyzed Collagen Peptides, All-Natural Aid for...
Products contain alfalfa seed recalled by the supplier and may be contaminated with E. coli and/or Salmonella (downstream recall) Product details: Todd's Seeds Alfalfa Sprouting Seeds,...
Microbial contamination of topical product. Product details: Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles...
Defective Container; packets were found to be either empty or partially full. Product details: Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal...
Lack of Assurance of Sterility Product details: FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109....
Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. Product details: Zoladex (goserelin) implant, 3.6 mg, One...
Failed dissolution specifications. Product details: Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9,...
Microbial contamination of topical product. Product details: Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233,...
Crystallization Product details: Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05
Failed Dissolution Specifications: below specification Product details: Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc.,...
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years....
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking,...
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM...
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years....
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years....
Due to blood-to-glycol leak in the heat exchanger. Product details: Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog...
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if...
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study,...
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of...
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years....
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM...
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years....
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The...
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years....
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the...
Jalapenos have the potential to be contaminated with Salmonella Product details: PICO DE GALLO-HOT-6/9oz HEB-PICO-HOT-12/14oz
Unapproved dye Ponceau 4R Product details: Hexing Haw Balls candy; packaged in 200g/0.44 lb./7.05 oz clear plastic bag; Ingredients: haw, white sugar, water.; Serving suggestion: ready to...
Potential contamination with Salmonella. Product details: Pico De Gallo. Ingredients: Tomato, Onion, Jalapeno Pepper, Cilantro, Garlic, Salt, Black Pepper. Net Wt: 7 oz. Keep Refrigerated....
Potential contamination with Salmonella. Product details: Pineapple Mango Salsa Mild. Ingredients: Mango, Pineapple, Pasteurized Lime Juice, Pasteurized Lemon Juice, Jalapeno Pepper,...
Jalapenos have the potential to be contaminated with Salmonella Product details: HEB-PICO-MEDIUM-12/14oz PICO DE GALLO-MEDIUM-6/14oz PICO DE GALLO-MEDIUM-6/9oz...
Potential contamination with Salmonella. Product details: Spicy Guacamole. Ingredients: Guacamole, Pico De Gallo. Spec Sheet: Guacamole (Avocado, Pico De Gallo, Serrano Peper, Lime Juice,...
Product may be contaminated with Salmonella Product details: Martina brand Fresh Whole Mangoes; Individual whole mangoes, variable weight; 9 mangoes per carton box
Potential contamination with Salmonella. Product details: Taco Dip. Ingredients: Refried Vegetarian Beans *** Guacamole (***Pico De Gallo [***Jalapeno Pepper]***), Pico De Gallo...
Potential contamination with Salmonella. Product details: Spicy Pimento Cheese Dip. Ingredients: Sharp Cheddar Cheese *** Cream Cheese *** Piquillo Peppers *** Jalapeno Pepper, Mayonnaise...
The Firm was notified by NJ Department of Health of two samples collected from tuna with reported high levels of scombrotoxin. Product details: Buckhead, Tuna, 10lb cs, 12lb cs, 15lb cs,...
Peanuts & Eggs. The firm list peanuts in the ingredient statement but omitted them from the contain statement. They also have eggs listed in the contain statement but there are no eggs in...
Carrot decoration contains Yellow #5 and Yellow #6 which is not listed on finished product label. Product details: Elegant Foods Carrot Cake, 9". 14 Servings. Keep Refrigerated/Frozen. 537...
Potential contamination with Salmonella. Product details: BH Bold Chef Salad Kit. Ingredients: Iceberg Lettuce, Pico De Gallo (***Jalapeno Pepper), Jalapeno Ranch Dressing (***Jalapeno...
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Product details: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector....
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated...
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. Product details: Midmark IQvitals Zone, automatically and noninvasively...
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the...
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the...
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed. Product details: CombiSet Hemodialysis Blood Tubing...
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the...
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay. Product details: nGenuity Patient...
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of...
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the...
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the...
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). Product details: Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1....
Lack of Assurance of Sterility Product details: Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road,...
Defective Delivery System: Possibility of no medication in the prefilled pen. Product details: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use...
Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within...
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. Product details: Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured...
Lack of Assurance of Sterility Product details: Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive,...
Lack of Assurance of Sterility Product details: Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by...
Lack of Assurance of Sterility Product details: Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream,...
cGMP Deviations Product details: MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan,...
Subpotent Drug Product details: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West,...
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026). Product...
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent....
Jalapenos have the potential to be contaminated with Salmonella Product details: NatureBest Mild Cheddar & Jalapeno Stuffed Mushrooms 8oz (227g) HEB SI JAL POP STFFD MUSHRM-6/8oz
Jalapenos have the potential to be contaminated with Salmonella Product details: SOUP MIX-6/58oz Tray, PPS971 CLR PET 900/cs 32cs/pal, film-sealed (18" 16 Micron Perserva Wrap 5000/rl),...
Potential contamination with Salmonella. Product details: Salsa Verde Mild. Ingredients: Whole Tomatillos (***), Roasted Poblano Chile, Jalapeno Pepper, Cilantro, Serrano Pepper, Garlic,...
Jalapenos have the potential to be contaminated with Salmonella Product details: HEB-GUAC KIT-MILD-3/57.5oz
Potential contamination with Salmonella. Product details: Mild Pico De Gallo. Ingredients: Tomatoes, Red Onions, Lime Juice Concentrate, Jalapeno Peppers, Garlic, Cilantro, Salt. Net Wt:...
Undeclared sulfites Product details: Elegant Foods Golden Raisins, 5 pound. 537 Atlas Ave, Madison, WI 53714.
Potential contamination with Salmonella. Product details: Hot Pico De Gallo. Ingredients: Tomatoes, Red Onions, Jalapeno Peppers, Lime Juice Concentrate, Serrano Peppers, Cilantro, Garlic,...
Jalapenos have the potential to be contaminated with Salmonella Product details: PICO DE GALLO-MILD-4oz PICO DE GALLO-MILD-6/14oz PICO DE GALLO-4/5# PICO DE GALLO-1/5# PICO DE...
Potential contamination with Salmonella. Product details: Salsa Fresca Medium. Ingredients: Tomato, Yellow Onion, Jalapeno Pepper, Pasteurized Lemon Juice, Garlic, Salt, Cilantro, Ground...
Failed Stability Specifications Product details: Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:...
Failed Stability Specifications Product details: Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:...
Failed Stability Specifications Product details: Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:...
Superpotent Drug Product details: Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by:...
Failed Stability Specifications Product details: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:...
Failed Stability Specifications Product details: Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:...
Failed Stability Specifications Product details: Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by:...
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). Product details: Lidocaine Ointment...
Failed Stability Specifications Product details: Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro...
Lack of Assurance of Sterility Product details: Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL...
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials. Product...
Reusable access port system may crack or seperate during use. Product details: REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to...
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to...
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. Product details: Haylard 18G SINGLE SHOT EPI...
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus...
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events. Product...
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including...
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the...
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to...
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised...
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the...
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. Product details: Happiest Baby, Inc SNOO Sleep Sack, X-Small...
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be...
Sesame is not declared in the ingredient statement but is declared in the statement of identity. Product details: Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12...
Foreign object: metal fragments Product details: Bread Pudding with Vanilla Sauce - KIT NET WT 4 LB (1.81Kg) UPC 7 22515 91732 0 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Undeclared FD&C Red No. 40 Product details: Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bags
Undeclared FD&C Red No. 40 Product details: Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bags
Undeclared milk. Product details: OLA-OLA Pounded Yam (Iyan) IYANINSTANT, NET WT. 2 lbs., 4 lbs., 5 lbs., 10 lbs, packed in flexible plastic bags. INGREDIENTS: Processed Dehydrated Yam...
Product has high patulin levels Product details: Weis (Fresh From the Orchard ) Pasteurized Apple Cider, Contains 100 % Juice, the product comes in the following sizes: Pints, 1/2 Gallon,...
Sesame is not declared in the ingredient statement but is declared in the statement of identity. Product details: Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS:...
Foreign object: metal fragments Product details: Bread Pudding with Vanilla Sauce NET WT 13.8 OZ (39g) UPC 7 22515 28044 8 Ukrop's Homestyle Foods, LLC Richmond, VA 23230
Contaminated with Salmonella Product details: Food to Live Organic SuperGrass Powder; 6 oz, 12 oz, 1 lb, 4 lb
Product may be contaminated with Salmonella. Product details: THE HAMPTON GROCER brand; Lacnola; SMALL BATCH LACTATION GRANOLA, 8oz, stand up pouches; NUTRIENT DENSE INGREDIENTS + MORINGA;...
Milk is not declared in the Contains statement. Product details: Prince PAN DE MANTECA; SPANISH STYLE; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT...
Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella Product details: Item #DIPSAU0205RFS Salsa Autentica 5 lb. packaged in round plastic...
Sesame is not declared in the ingredient statement but is declared in the statement of identity. Product details: Prince Sesame FRENCH BREAD; LONG FRENCH; Net Wt. 10 oz (284g);...
Undeclared FD&C Red No. 40 Product details: Wonton Specialist Inc. Wonton Skin, 16 oz - packaged in foam tray overwrapped with clear plastic
Undeclared FD&C Red No. 40 Product details: Wonton Specialist Inc. Lo Mein Noodle, 16 oz, packaged in clear plastic bags
Product tested positive for undeclared milk allergen. Product details: Organic Cheddar Type Seasoning, NET WT: 50 lbs. Product is packaged in bulk poly-lined paper bag. Savor Seasonings,...
Undeclared FD&C Red No. 40 Product details: Wonton Specialist Inc. Dumpling Skin, 16 oz - packaged in foam tray overwrapped with clear plastic
Products were manufactured with jalapenos that have the potential to be contaminated with Salmonella Product details: Item # DIPPIC0205RFS Pico de Gallo 5 lb packaged in round plastic...
Undeclared FD&C Red No. 40 Product details: Wonton Specialist Inc. Wonton Noodle, 12 oz - packaged in foam tray overwrapped with clear plastic and 5lb - packaged in clear plastic bags
CGMP Deviations Product details: Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter...
CGMP Deviations Product details: Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare...
CGMP Deviations Product details: Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile...
CGMP Deviations Product details: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and...
Failed dissolution specifications. Product details: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions,...
Presence of Foreign Tablets/Capsules Product details: traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia,...
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. Product details: THE ONE SPF 50 INVISIBLE SUNSCREEN GEL,...
The firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying. Product details: Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per...
Undeclared allergen (tree nuts): hazelnut, cashew, and pistachio. Product details: Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass jar with white...
Undeclared Wheat. Product details: Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC 6 28634 44216 6. Ingredients: Broccoli, Cauliflower, Tapioca...
Potential E. coli and Salmonella contamination Product details: Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volunteer Dr. Cookeville, TN 38506
Undeclared milk and pecans Product details: Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47oz
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution. Product details: Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter...
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. Product details: Glutathione 200 mg/mL, 30 mL sterile multidose vial,...
Labeling: Label Mix-up Product details: Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton...
Presence of particulate matter: Particulates identified as fiberglass Product details: 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter...
Hemodialysis concentrates contain high endotoxin levels Product details: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn. Product details:...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Product details: Products that...
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. Product details: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case;...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Product details: Products that...
Due to a damaged (over stretched) membrane tail that causes an intermittent fault. Product details: HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067...
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Product details: Products that...
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. Product details: Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case;...
Hemodialysis concentrates contain high endotoxin levels Product details: Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. Product details: Products that...
Hemodialysis concentrates contain high endotoxin levels Product details: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion...
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. Product details: Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit:...
Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility assurance due to to wrinkles in the paper lidding which may breach the seal...
Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially compromised sterility. Product details: Kit: Epidural/Pain TQC 20/Cs, REF: 82465...
Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on...
Undeclared peanuts. Product details: Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
Label does not declare walnuts in English Product details: Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc....
Foreign object: products may contain glass pieces Product details: Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit...
Foreign object: products may contain glass pieces Product details: Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit...
CGMP Deviations Product details: Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile,...
CGMP Deviations: Potential contamination of raw material Product details: Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar,...
CGMP Deviations Product details: Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile...
CGMP Deviations Product details: Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter...
CGMP Deviations Product details: Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter...
CGMP Deviations Product details: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter...
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may...
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to...
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified Product details: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot...
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on...
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia....
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw...
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden...
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. Product...
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to...
Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the...
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia....
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment. Product...
The product contains 1,4-DMAA, Phenylethylamine and Phenibut. Product details: Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
Product had a presumptive positive test result for Listeria monocytogenes Product details: Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese,...
Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list Product details: Clear glass bottle with black screw lid...
Foreign object: products may contain glass pieces Product details: Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual...
The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut)....
Foreign object: products may contain glass pieces Product details: Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual...
The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut)....
Foreign object: products may contain glass pieces Product details: Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce, UPC 041548816678, packaged in paper...
Undeclared peanuts. Product details: BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000084
Undeclared Egg Allergen Product details: Jalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.
Label does not declare walnuts in English Product details: Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315...
Foreign object: products may contain glass pieces Product details: Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual...
Label does not declare walnuts in English Product details: Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas...
Product may have been improperly pasteurized. Product details: Mehadrin Chocolate Leben; 6 OZ (170g) CUPS, UPC: 070784023144
Inaccurately declared nutrients including Potassium (overstated) and Calcium (overstated). Product details: Prospector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3.5oz
Due to potential E. coli O145:H28 contamination Product details: Organic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx...
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU). Product details: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617,...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617,...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only,...
Failed content uniformity specifications. Product details: Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108,...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617,...
Presence of particulate matter: glass and stopper piece Product details: Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC,...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617,...
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing Product details: Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx...
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. Product details: Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20...
Presence of Particulate matter. Product details: Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC...
Kits contain a potentially contaminated component which were recalled by the manufacturer Product details: Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y;...
Kits contain a potentially contaminated component which were recalled by the manufacturer Product details: Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU...
Kits contain a potentially contaminated component which were recalled by the manufacturer Product details: Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU...
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may...
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning...
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may...
Kits contain a potentially contaminated component which were recalled by the manufacturer Product details: Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L;...
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. Product details: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider,...
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines....
Software issue may cause measurements to be displayed inaccurately. Product details: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. Product details: Alphenix Models INFX-8000C...
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of...
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning...
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex. Product details: Halyard TOTAL JOINT Model/Catalog Number:...
Kits contain a potentially contaminated component which were recalled by the manufacturer Product details: Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine. Product details: Kian Pee Wan Capsules, 30-count bottles
CGMP Deviations:Noted during FDA inspection Product details: SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP,...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile...
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin. Product details: Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only,...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx...
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. Product details: Optiray Imaging Bulk Package-350, Ioversol Injection 74%,...
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. Product details: CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL,...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only,...
Lack of assurance of sterility. The recall is due to potential contamination Product details: CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile...
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material Product details: SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile...
Presence of Particulate Matter Product details: Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix,...
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). Product...
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Product details: Cardinal Health Presource Kits: 1) ENT...
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if...
Due to an increase rate of balloon pinhole defects. Product details: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in...
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Product details: Cardinal Health Presource Kits: 1)...
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced...
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. Product details: Cardinal Health Presource Kits: 1) KIT,...
Firmware issue potentially leading to loss of geometry movements. Product details: Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058....
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. Product details: GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The...
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced...
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms,...
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position. Product details:...
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. Product details: Boston Scientific Enhance...
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if...
Products may be contaminated with Listeria monocytogenes. Product details: Selectos Latinos Requeson Mexicano Mexican Cottage Cheese, Net Weight 16 oz, packed into retail-sized clear...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby, Marble Jack, Yummy...
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label. Product details: Spicy...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habanero Peppers)....
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble Jack). Sold...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Snack Pack Assorted Pepperjack Stix (Jalapeno Cheddar, Pepper...
Possible foreign object (thin, soft plastic strands). Product details: Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree, 4oz/113g pouch, UPC 815367010780, PTO Item 10720....
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Soft Cuajada in Brine, sold in five (5) gallon and two (2) gallon buckets. Unknown information:...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Sharp Cheese Snack Pack Sharp Stix White or Yellow. Sold in approximate 0.40-lb (6.4oz) units....
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (3-in-a-Pack Assorted Jalapeno Cheddar, Pepper Jack, Sizzling Colby)....
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Soft Ricotta (Requeson), and Soft Ricotta with Jalapenos (Requeson Con Chile). Sold in 2- and...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, mild cheese variety (Fresh Cheddar Curd). Sold in approximate 0.75-lb and 1.5-lb box units....
Flexible food pouch may release thin plastic strips into food. Product details: Flexible food pouch (3-layer foil, spouted, #CP6088), manufactured for packaging Pumpkin Tree Peter Rabbit...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Flavored Cheese (Old Bay Cheddar). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb...
Undeclared tadalafil Product details: Ashfiat Alharamain Energy Support 250ml/8fl. oz.
Undeclared milk from lactose. Product details: Big Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packaging.
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products. Product details: FLOUNDER SASHIMI WITH SAUCE;...
Possible Salmonella Enteritidis Product details: Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net Wt 21 oz (1lb 5oz) 596g, UPC...
Undeclared peanuts Product details: Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case.
Potential Cyclospora contamination. Product details: MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, Romaine, Carrots, Red Cabbage products.
Undeclared Red #40. Product details: Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE. MANUFACTURED FOR: HONEYVILLE, INC....
Label declares cream and cheese, but Milk is not declared Product details: Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.
Possible Salmonella Enteritidis Product details: Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage Free Grain Fed, Medium, 12...
Undeclared allergen (egg) Product details: KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055. 6 - 3 lb pouches, Net Wt: 18 lb. (8.16Kg). Fully Cooked. Keep Frozen. Distributed By: Kerry...
Lack of Assurance of Sterility Product details: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR...
Lack of Assurance of Sterility Product details: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR...
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received. Product details: Azelaic Acid Gel, 15%, 50...
Presence of precipitate Product details: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC,...
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. Product details: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%,...
Incorrect Product Formulation Product details: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose...
undeclared egg Product details: Blank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES, 4.5 oz clear plastic package
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Smoked Pepper Cheese Varieties (Jalapeno Cheddar), sold in 1/2-lb and 1-lb units. Unknown...
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products. Product details: Sliced Korean Halibut with Soy...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Soft Cuajada crumbs. Unknown information: packaging, labeling, or total quantity of product...
Allergen missing from contains statement: fish Product details: "***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch, pouches packed in brown paperboard cartons (600...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Soft Cuajada (vacuum sealed), sold in 14oz- and 2.5 lb clam shells, and 5-lb bags. Unknown...
Product contaminated with Listeria monocytogenes. Product details: Clover Hill Dairy LLP, Smoked Cheddar Cheese Varieties (Cheddar, White Cheddar). Sold in 1/2-lb and 1-lb units. Unknown...
shortfill; reports of empty capsules. Product details: Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279...
Presence of Particulate Matter; identified as stainless steel Product details: Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove...
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Product details: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by:...
Presence of Particulate Matter; identified as stainless steel Product details: Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove...
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability Product...
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability Product...
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability Product...
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health...
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Product details: Brand Name: U2 Total Knee System Product Name:...
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic...
Due to a defective circuit board that overheats Product details: Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version:...
Devices could potentially contain an occluded or partially occluded Guedel Airway tip. Product details: FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002....
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of...
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." Product details: REF # D23354,...
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange...
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. Product details: Brand Name: U2 Total Knee System...
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds....
Potential for breach in sterile barrier of device packaging. Product details: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5;...
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. Product details: Brand Name: U2 Total Knee System Product Name:...
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the...
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the...
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Nuez, 1 Bar (81.7 g), with UPC 827912008548
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Tamarindo, 1 Bar (81.7 g), with UPC 827912008593
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than...
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Arroz con Leche, 4 oz (85 g), with UPC 710594511843
Undeclared peanuts Product details: OLA-OLA POUNDED GROUNDNUTS (INTWILO) NET WT. 32 oz., 2 lbs. (0.907 kg) Distributed by: Yusol International Foods Sacramento, CA 95828 Product of USA...
Foreign material (Glass) was found in the product. Product details: Ruby, Artichoke Hearts Quartered, 5 LB 8 OZ (2500 G) DRAINED WT 3 LBS 6 OZ (1550G), Can, 6 cans per case, Store in dry...
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Fresa Leche, 4 oz (85 g), with UPC 710594511850
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Mango, 3.7 oz (81.7 g), with UPC 827912008494
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Limon, 4 oz (85 g), with UPC 710594511836
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487
Ambient storage of the product may lead to Clostridium botulinum toxin formation. Product details: Brooklyn Roasting Company Pasteurized Cold Brew Concentrate; 2.5gal; bag in a box...
Undeclared colors: Yellow#5, and Yellow#6. Product details: Man Fon Inc. Won Ton Wrappers Extra Thin; Net Wt. 10 oz; UPC# 757168 977315, Keep Refrigerated, Can be Frozen. Sold in 48 units...
No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6. Product details: Wonton Wrappers packed into clear flexible plastic bag and sold as 40 units (16oz bags)/case. Wonton Wrappers...
Unapproved food additive: sassafras bark. Product details: Vintage Roots Root Beer Syrup, packaged in glass bottle. Net Wt. 8oz. (236.6 mL). Distributed by Vintage Roots, PO Box 12, Brady,...
FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam. Product details: Modern Warrior Ready, Dietary Supplement, 60 CAPSULES
Undeclared sodium tripolyphosphate (STTP) Product details: Island Pacific IMITATION CRAB FLAKES NET WT: 1.0 LB (454g) UPC: 0000000175012 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK...
Undeclared sodium tripolyphosphate (STTP) Product details: Island Pacific IMITATION CRAB STICKS NET WT: 1.0 LB (454g) UPC: 0000000175029 PRECOOKED SERVE HOT OR COLD INGREDIENTS: POLLOCK...
Undeclared sodium tripolyphosphate (STTP) Product details: NAUTILUS IMITATION CRAB STICKS NET WT: 1.0 LB (454.0g) UPC: 878665000235 Precooked - serve hot or cold Ingredients: Pollock...
Undeclared Allergen (Fish) Product details: Fusia, Asian Inspirations, Kimchi & Tofu Kimbap, 8.1 OZ (230 g), Paper Film Wrapper, 12 packages per case , 6 ea: Kimchi & Tofu Kimbap / 6 ea...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR...
Presence of Particulate Matter: Hair was found in products Product details: Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR...
Lack of Assurance of Sterility Product details: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The...
Presence of Particulate Matter: Hair was found in products Product details: Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx...
Foreign material found in product (identified as metal shavings) Product details: DQ Chocolate Reduced Fat Ice Cream Mix, 5 GAL (18.9L). Keep refrigerated.
Products may be contaminated with Listeria monocytogenes. Product details: Requeson (soft ricotta) 1 lb. packed into a clear clamshell package with no labeling information. "Requeson" is...
Firm's finished product label does not declare the source of marine collagen which was determined to be fish. Product details: Mellish Island Super Skin; Dietary Supplement; 60 Capsules, 2...
Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III...
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris...
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. Product details: Brand Name:...
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Product details: Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number:...
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation,...
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Product details: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number:...
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy. Product...
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM...
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Product details: Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number:...
Potential E. coli O145:H28 Contamination Product details: Organic Whole Blueberries, Net Wt 10 oz (284g) plastic bag, packed in 8 bags per case of 10 oz each. Keep Frozen
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Pina Colada, 1 Bar (81.7 g), with UPC 710594511225
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than...
Lack of Assurance of Sterility Product details: Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR...
Presence of Particulate Matter: Hair was found in products Product details: Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only,...
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation...
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. Product details: FARASTAR...
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. Product details: Halyard...
Due to manufacturing issues, reperfusion catheters may fractures Product details: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system...
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered...
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could...
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return...
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact...
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue...
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. Product details: FARASTAR Pulsed Field Ablation Generator,...
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become...
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. Product details:...
Failed Impurities/Degradation Specifications Product details: Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma...
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator Product details: BD ChloraPrep Clear, (2% w/v chlorhexidine...
Lack of Assurance of Sterility Product details: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc.,...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL)...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included,...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34,...
Subpotent Drug: Low out of specification assay results performed during long-term stability testing. Product details: Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.);...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb...
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). Product details: Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01,...
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Product...
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose...
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually...
Potential for brush heads to break. Product details: Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break. Product details: Papablic Replacement Brush Heads. Model Number: Papablic18B
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually...
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. Product...
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). Product...
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been...
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually...
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. Product...
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region....
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). Product...
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been...
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. Product details: General Biospy...
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Nanche, 1 Bar (81.7 g), with UPC 827912008449
Potential for spoilage. Product details: Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ. (411 g) Microwave: Place soup in a microwave-safe bowl. Cover. Cook for 1.5-2 minutes....
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Grocella, 1 Bar (81.7 g), with UPC 827912008531
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Vainilla, 4 oz (85 g), with UPC 710594511829
Product may contain metal fragments. Product details: WY Duck Sauce, 0.35 oz. (10 g), flexible film packets, 500 packets per case.
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Coconut, 4 oz (85 g), with UPC 710594511867
Undeclared milk allergen. Product details: Winfield's CWB Chocolate Bar, packed in clear cello bag with fabric bow on top. Manufactured by CBSL Commissary (DBA Winfield's Chocolate Bar)...
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Product details: Ice Pop, D'Dioses Rompope, 4 oz (85 g), with UPC 710594511812
Potential foreign material (glass) Product details: Pillsbury Bread Rolls, Hard Roll Dough. 180 units / 2.25oz each. Net Wt. 25.31 lb (11.48kg) Package UPC 721582-13283 4. Case UPC...
Potential foreign material (glass) Product details: Pillsbury Bread Rolls, Kaiser Roll Dough. 144 units / 2.5oz each. Net Wt. 22.5 lb (10.2kg) Package UPC 7 21582-13288 9. Case UPC...
Product not adequately pasteurized Product details: Joy Pineapple Lassi 16 oz.
Improperly eviscerated which may result in Clostridium botulinum contamination Product details: Dried Herring Fish 7 oz.
Potential contamination with plastic material Product details: MorningStar Farms Buffalo Chik'n Nuggets, 100% Plant Protein Vegan Nuggets, Net Wt. 10.5 oz. (298g), packaged in a resealable...
Undeclared allergen (milk) and process deviation (product not held under refrigeration as required) Product details: Pepperoni Rolls, Net Wt. 5 oz (141g), individually packaged in a clear...
Undeclared peanuts. Product details: FIRST STREET Dark Chocolate Raisins Net Wt. 9 oz. (255g) UPC 797565011830 INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, MILK FAT,...
Dietary supplement product Vista MAX contains undeclared Yellow#5. Product details: Vista MAX; Dietary Supplement, 90 Capsules. Serving Size: 4 Capsules; Distributed by: Vision of Health,...
Dietary supplement product Ocular Plus contains undeclared Yellow#5. Product details: Ocular Plus with Lutein, Zeaxanthin, and Omega 3-6-9; Dietary Supplement, 200 Capsules. Serving Size:...
Elevated coliforms Product details: Plastic 1-gallon clear pail blue label which reads in part as "BLUE RIBBON CLASSICS FRENCH VANILLA, MFD. BY WELLS ENTERPRISES, INC. D/B/A WELLS DAIRY,...
Product may be contaminated with Clostridium botulinum. Product details: a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7...
Potential contamination with plastic material Product details: MorningStar Farms Hot & Spicy Sausage Patties, 100% Plant Protein Vegan Sausage Patties, Net Wt. 8 oz. (228g), packaged in a...
Undeclared Sesame allergen Product details: Smoked Sausage Spice 32.86#
undeclared soy Product details: Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough, 8-oz pouch 12 cookies per pouch, UPC 8 50073 08700 8, 8 pouches per case
Undeclared Sesame allergen Product details: EC Hot Links Seasoning 45.05#
The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3. Product details: Wise Onion Rings, 3.75 oz, metalized film in cardboard cartons, 14 bags per case,
Undeclared Allergen (Soy) Product details: Vanilla Dessert Shells (Giant), 6 dessert shells/1 package, 1 dessert shell is approximately 23.67 grams. 1package is 142 grams. 1 package has 1...
Undeclared Sesame allergen Product details: Coopers Bbq 60 Gal Bean Mix box
Foreign material: small metal pieces Product details: Alabama Banana Pudding Marshmallow, 4 ounce 16 pieces of individual marshmallows packaged in a sealed plastic bag inside a printed...
Undeclared Sesame allergen Product details: JB Chicken Sknls 35.73#
Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging. Product details: High Valley Orchard Chocolate Covered Raisins,...
Undeclared Sesame allergen Product details: Johnny's Salad and Pasta Elegance 5.5 oz (UPC: 0-70381-10014-9) " Johnny's Salad and Pasta Elegance 2.75 oz (UPC: 0-70381-10013-2)
undeclared colors (yellow#5) Product details: Le Chef Bakery branded Mini Italian Pastry Assortment; 2.5 lbs/cs; (40 pieces/cs); packaged in generic food service packaging with white...
Subpotent drug Product details: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Subpotent drug Product details: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Subpotent drug Product details: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR...
cGMP deviations Product details: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC...
Lack of Sterility Assurance Product details: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset...
Subpotent drug Product details: Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302...
Subpotent drug Product details: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio...
Lack of Sterility Assurance Product details: Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics,...
Lack of Sterility Assurance Product details: Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset...
Lack of Sterility Assurance Product details: Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for:...
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification. Product details: Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for...
Subpotent drug Product details: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR...
Failed Impurities/Degradation Specifications Product details: Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr,...
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Product details: TERPENICOL Antifungal Solution, (Undecylenic...
Surgical dressing manufactured out of specification (greater thickness). Product details: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. Product details: GSP...
A product error defect may cause incorrect bracket placement. Product details: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages...
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. Product details: Olympus Single Use...
Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. Product details: Brand Name: Versius Surgical System US Product Name: Vesius...
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general...
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient...
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Product details: Brand Name: Fletcher CT/MR Shielded...
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem. Product details: 5008X...
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Product details: Brand Name: Brachytherapy Applicator...
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Product details: Brand Name: Geneva Product Name:...
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. Product details: TMINI Femur Tracking Array REF 109003 UDI-DI...
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. Product details: VITEK 2 AST-N447...
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe...
Potential presence of Salmonella. Product details: 1.5oz, 2oz Dirty Brand Salt and Vinegar Potato Chips , Plastic Bag.
Undeclared allergen, sesame. Product details: boichik bagles Pumpernickel Mix Bagels 6 pre-sliced bagels NET WT 26.5 OZ (1.66 LB) 750g Ingredients: Organic wheat flour ... Contains Wheat...
Potential presence of Salmonella. Product details: 2.0 oz Dirty Sour Cream and Onion Potato Chips, Plastic Bag.
Potential presence of Salmonella. Product details: 1.5oz Zapp's Bayou Blackened Ranch Kettle Chips, Plastic Bag.
potential salmonella contamination Product details: Motor City Pizza Co. 5 Cheese Bread Single retail pack; 22.43 oz. (1 lb. 6.4 oz.) 636g UPC 8 70375 00511 1; 6 retail units per case...
Product not adequately pasteurized Product details: Joy Saffron Cardamon Lassi 16 oz.
Potential Salmonella contamination Product details: Spring & Mulberry Mango Chili Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in an orange box, UPC 850055470033,...
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew. Product details: 6/11oz No Salt Sunflower Seeds
Potential Salmonella contamination. Product details: Spring & Mulberry Mulberry Fennel Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a burgundy box, UPC...
Product not adequately pasteurized Product details: Joy Plain Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized Product details: Joy Rose Lassi 16 oz.
The firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew. Product details: 25# Sunflower Seeds C/S
Incorrect Product Label; Roast Beef and Swiss closed face sub sandwich labeled as Turkey and Cheddar closed face sub sandwich Product details: Roast beef and cheddar closed face sandwich...
Product not adequately pasteurized Product details: Joy Sweet Lassi 16 oz.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the...
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the...
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the...
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Product details: Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured...
Lack of Assurance of Sterility Product details: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem...
Presence of Foreign Substance Product details: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL...
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the...
Subpotent Drug Product details: Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured...
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Product details: Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured...
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Product details: Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured...
Lack of Assurance of Sterility Product details: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501,...
Lack of assurance of Sterility: Product details: IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco...
Reduced or no recovery of some strains of Neisseria gonorrhoeae. Product details: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these...
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Product details:...
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these...
Potential sterile breach of the pouches in which devices are packaged. Product details: CRE Pro Wireguided 12-15mm 240cm
Due to out-of-specification, or potential out-of-specification, levels of endotoxins Product details: Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton)...
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality...
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients,...
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. Product details: 5855240...
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality...
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality...
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these...
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. Product details: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary...
Potential presence of Salmonella. Product details: 2.0 oz Dirty Maui Onion Chip, Plastic Bag.
Product not adequately pasteurized Product details: Joy Mango-Pina-Strawberry Lassi 16 oz.
Product not adequately pasteurized Product details: Joy Mango-Pina-Orange Lassi 16 oz., 64 oz.
Product not adequately pasteurized Product details: Joy Masala Chaash Lassi 16 oz., 64 oz.
Potential Salmonella contamination Product details: Spring & Mulberry Sea Salt Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a grey box, UPC 850055470071, Dist....
Potential Salmonella contamination Product details: Spring & Mulberry Lavender Rose Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a light blue box, UPC...
Product not adequately pasteurized Product details: Joy Mango Lassi 16 oz., 64 oz.
Potential Salmonella contamination Product details: Spring & Mulberry Mixed Berry Date-Sweetened Chocolate, Net Wt. 2.1 oz. (60g), individually packaged in a purple box, UPC 850055470026,...
Product not adequately pasteurized Product details: Joy Strawberry Lassi 16 oz.
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. Product details: Lacosamide Tablets, USP, C V,...
Presence of Foreign Substance. Product details: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Presence of Foreign Substance. Product details: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx...
CGMP Deviations Product details: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ...
CGMP Deviations Product details: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan....
sub potency Product details: Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Product details: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC...
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. Product details: BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and...
Subpotent Drug Product details: Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS,...
Lack of Assurance of Sterility Product details: PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Presence of foreign substance Product details: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN...
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. Product details: Perampanel CIII Tablets, 6mg, Rx only, 30...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Product details: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs,...
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Product details: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills,...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Product details: Off-Axis Comprehensive Shoulder System,...
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. Product details: Convenience kits...
Potential for thrombus formation during prolonged use of the introducer. Product details: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Product details: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs,...
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Product details: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Product details: Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs,...
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister,...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Product details: Off-Axis Alliance Glenoid, Right, 4-Peg,...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Marquesita de Chocolate y Vainilla [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Rollitos de Guava [image] Guava Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid plastic...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Rollitos de DulceLeche [image] Caramel Rolls The Original, Net Wt. 15 oz, packaged in a transparent and rigid...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Fresa [image] Strawberry Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Tiramisu [image] Cofee Cake The Original, Net Wt. 30 oz, packaged in a transparent and rigid plastic clamshell...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Marquesita de Mango [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent and...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Fresa y Chocolate [image] Stawberry & Chocolate Cake The Original, Net Wt. 48 oz, packaged in a rigid...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Mango [image] Mango Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Guava [image] Guava Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid...
Undeclared FD&C Red 40 Product details: ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic...
Potential physical contamination: dark spot was noticed on the bottom of container. Product details: MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL...
The product contains unapproved colors chlorophyll E140 and E141. Product details: .155 CRUNCHY CANNOLI GLUTEN FREE intended use: DESSERT condition: shelf stable shelf life: 12 month type...
Undeclared melatonin. Product details: Adndale Magnesium Glycinate Gummies 400 mg. Plastic bottle containing 90 gummies. Net weight: 11.36 ounces. Serving size: 2 gummies. UPC:...
Firm observed oily and sticky substance on direct food contact surface packaging of finished product. Product details: Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable...
Undeclared fish. Product details: azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY: AZUMA FOODS INTERNATIONAL INC., U.S.A....
The product contains unapproved colors chlorophyll E140 and E141. Product details: CANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging:...
Plain salt was labeled as iodized and iodized salt was labeled as plain. Product details: Salt
Product requires refrigeration but the label is missing a "Keep Refrigerated" statement Product details: Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon...
Undeclared Allergen (Soy) Product details: Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen
Defective container:may contain bottles with incomplete seals Product details: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook...
Defective container:may contain bottles with incomplete seals Product details: PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life,...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg,...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg,...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line...
Subpotent Drug Product details: Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC...
Failed Dissolution Specifications Product details: Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional...
Defective container:may contain bottles with incomplete seals Product details: Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g),...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes,...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook...
CGMP Deviations; deficiencies observed during FDA inspection Product details: Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook...
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 Product details: VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50...
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 Product details: VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface...
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. Product details: Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of...
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. Product...
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. Product details:...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. Product details:...
Due to 11 volt Backup Battery failures. Product details: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle,...
Lack of Assurance of Sterility Product details: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S....
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY:...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets,...
Potential contamination with lead. Product details: DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Napolitano [image] Neapolitan The Original, Net Wt. 22 oz, packaged in a transparent and rigid plastic clamshell...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Capuchino [image] Capuchino Cake The Original, Net Wt. 63 oz, packaged in a transparent and rigid plastic...
May contain metal pieces Product details: Farm Rich Pizza Cheese Crunchers
Premature lipid oxidation causing quality issue potentially causing product to have an off odor and bitter taste. Product details: NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC,...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Dulce de Leche [image] Caramel Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent...
Imported Enoki Mushrooms tested positive for Listeria Monocytogenes. Product details: HH Fresh Trading Corp. (branded) ENOKI MUSHROOM; Premium Quality; Net WT/ Poids Net 150g(5.29oz)...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cake de Coco [image] Coconut Cake The Original, Net Wt. 47 oz, packaged in a rigid plastic clamshell container...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Cheesecake de Mango [image] Mango Cheesecake The Original, Net Wt. 26 oz, packaged in a transparent and rigid...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Jumbo Brazo Gitano Caramelo [image] Jumbo Caramel Roll The Original, Net Wt. 40 oz, packaged in a rigid plastic...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell...
Undeclared colors (Yellow #5, Yellow #6, and/or Red #40). Product details: Marquesita de Dulceleche [image] Delighted Flavored Cakes The Original, Net Wt. 16 oz, packaged in a transparent...
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio. Product details: WeiKFiELD Custard Powder Kesar Pista, Net Wt....
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis Product details: Minocycline Hydrochloride...
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. Product details: Gas-X Extra Strength, SIMETHICONE...
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution Product...
Microbial contamination of sterile products Product details: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by:...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Product details: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules...
Failed Impurities/Degradations Specifications Product details: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02...
Presence of Particulate matter: Particulate matter identified as glass. Product details: DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile,...
Microbial Contamination of Non-Sterile Products Product details: BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle,...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Product details: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx...
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Product details: Primidone Tablets, USP, 50...
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. Product...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Product details: Brand Name: CGuard¿ Prime Carotid...
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock...
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Product Name: CORFLO* Safety PEG Kit with...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Product Name: MIC Safety Percutaneous...
The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. Product details: Mahurkar Elite PASS Trays; Description (Product...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Product Name: MIC Safety Percutaneous...
Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Product details: Brand Name: CORFLO Product Name: CORFLO...
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Product details: Brand Name: CGuard¿ Prime Carotid...
Reusable electrodes may not meet expected performance levels. Product details: Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF:...
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. Product details: NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog...
Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128...
Sterile anchors my lack sterility assurance. Product details: Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Sesame Seeds White were labeled as Curry Powder Sweet. Product details: Lunds & Byerly's Curry Powder Sweet
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Cookie Dough ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed...
Products may be potentially contaminated with Salmonella. Product details: White Cheddar Seasoning packaged in the following sized containers: 1. Net Wt. 1.2 oz (34g) Distributed by:...
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination Product details: Aramark Cheese Sauce New & Improved, 25 lb., packaged in a...
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Mint Chip ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by...
Products may be potentially contaminated with Salmonella. Product details: Karlsburger Kitchens Garlic N Cheese Topper, Net Wt: 20 oz. (567g). Distributed by: Karlsburger Foods, Inc.,...
Products may be potentially contaminated with Salmonella. Product details: #003020 Sour Cream & Onion, Net Wt: 10 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094.
Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame. Product details: Market of Choice...
Product does not meet label claim for Vitamin E. Product details: Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml...
Products may be potentially contaminated with Salmonella. Product details: #003740 Dill & Garlic Seasoning, Net Wt: 10 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094.
Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination Product details: 1) Cheese Sauce Mix, 25.5 oz., packaged in a sealed poly bag...
Products may potentially be contaminated with Salmonella. Product details: ANGEL branded STRAWBERRY SOFT-SERVE powder; 10- 2-pound bag/case NO UPC.
Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella. Product details: Malazi 100% PURE SUDANESE SESAME Tahina...
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified. Product...
Possible carbon steel foreign material (1-2mm) Product details: Betaine Anhydrous, 2055kg, material packed in foil bags inside 15kg cardboard box Label reads in part as "***BETAINE...
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Strawberry ORGANIC SUPER PREMIUM ICE CREAM ONE QUART (946mL) ONE PINT (473mL) Produced...
Un-eviscerated fish may be contaminated with clostridium botulinum Product details: Hellas Meze Golden Smoked Whole Herring
Products may be potentially contaminated with Salmonella. Product details: #0083004 Ranch Seasoning, Net Wt: 25 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094.
Potential contamination with foreign objects (metal pieces). Product details: STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed...
Products may be potentially contaminated with Salmonella. Product details: #007560 Fiery Hot Seasoning (Reduced Salt), Net Wt: 25 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094
The product may contain undeclared allergens (cashews, pistachios), and dried cherries. Product details: SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC...
Products may be potentially contaminated with Salmonella. Product details: #009530 Ranch Seasoning, Net Wt: 50 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094.
Products may be potentially contaminated with Salmonella. Product details: #800414/003729Butter Parsley, Net Wt: 50 lbs. JCB Flavors, 1224 Clark St. Watertown, WI 53094
Potential contamination with Salmonella Product details: 72% CACAO CHOCOLATE WITH DATE SUGAR WAFERS Ingredients: Cacao Beans, Organic Date Powder, Organic Cocoa Powder Net Wt 25lb (11.3kg)...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY:...
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Product details: Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets,...
Presence of foreign substance: small metallic particles in chewable tablets. Product details: EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets,...
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona Product details: Xyvona...
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the...
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching...
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential...
Temperature probe devices lack FDA clearance. Product details: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. Product details: Atlan...
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the...
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Product details: BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be...
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching...
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the...
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. Product details: BD Pyxis Mini Main REF: 349 Medication cabinet
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. Product details: Arvis Hip & Knee 3.0 Instrument Set, REF:...
Product was made with milk powder recalled by the supplier due to Salmonella contamination. Product details: Ellsworth Sour Cream + Onion Seasoning, Part #: 180000113. Net Wt 25.00 lbs...
potential presence of Salmonella Product details: Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
Potential contamination with Salmonella. Product details: GHIRARDELLI SWEET GROUND POWDER WHITE CHOCOLATE FLAVORED NET WT 50oz (3lbs 2oz) 1.41kg Distributed by Ghirardelli Chocolate...
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Menopause Bully 16 oz and 32 oz.
potential to be contaminated with Salmonella Product details: Solina 6036195 Ranch Seasoning, 50lb bag
Product was made with milk powder recalled by the supplier due to Salmonella contamination. Product details: VG7274D1 Natural Cream of Mushroom Type Flavor, Net Weight: 50 lbs. bag. Item...
potential presence of Salmonella Product details: Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal Sleep Spray. Dosage: 6...
potential to be contaminated with Salmonella Product details: Solina 6036443 Cheddar Cheese Powder Seasoning, 50lb bag
Product was made with milk powder recalled by the supplier due to Salmonella contamination. Product details: Blackstone Parmesan Ranch Seasoning, Net Wt 7.3 oz (207g). UPC 7 17604-04106 2....
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal B12 Spray. Dosage: 3 sprays...
Potential contamination with Salmonella. Product details: GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX FROZEN HOT COCOA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk ***...
potential to be contaminated with Salmonella Product details: Solina 6036087 Cr¿me Fraiche Spice Seasoning, 25lb bag
potential to be contaminated with Salmonella Product details: Solina 6036277 Garlic Cream Sauce Seasoning, 40lb bag
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal Kids Liquid Multivitamin...
potential to be contaminated with Salmonella Product details: Solina 6036554 Parmesan Breadstick Sauce Seasoning, 40lb bag
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule. Product details: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip,...
Subpotent Drug Product details: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900,...
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Product details: Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx...
Presence of particulate matter: a white thread-like structure in the cartridge Product details: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin...
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit Product details: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by:...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by:...
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus. Product details: MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%),...
Lack of Assurance of Sterility Product details: cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per...
Defective Container; packets were found to be either empty or partially full. Product details: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed...
Failed Impurities/Degradation Specifications Product details: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals,...
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may,...
Products were made with recalled California Dairies milk powder due to Salmonella. Product details: Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse,...
Undeclared Milk Allergen, Product details: Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
Undeclared Milk Allergen, Product details: Wawa Diet Lemonade Pint (16oz), Plastic bottle
Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products. Product details: (BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item#...
Products were made with recalled California Dairies milk powder due to Salmonella. Product details: giant eagle Baked Pita Chips with Parmesan, Garlic & Herb Bagel Crisps, Net Wt 7.33 oz....
Products were made with recalled California Dairies milk powder due to Salmonella. Product details: Parmesan & Herb Bagel Crisps, Item Number 18139, Net Weight: 10 lbs. Legacy Bakehouse,...
Undeclared Milk Allergen, Product details: Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle
Undeclared Milk Allergen, Product details: Wawa Fruit Punch Pint (16oz), Plastic bottle
Possible cross-contamination resulting in undeclared allergen ingredient (Peanut) Product details: Fly By Jing (branded) Creamy Sesame Noodles; 3.8 oz packets. Sold in single and 4 packs....
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. Product...
Failed Stability Specifications Product details: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a...
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing...
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a...
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister...
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. Product details: RelayPro...
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. Product details: Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model...
Nitrile Exam Glove failed to meet specifications chemical permeation performance. Product details: Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772...
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Fibroid Bully 16 oz and 32 oz.
Seasoning was made with recalled California Dairies milk powder due to Salmonella contamination. Product details: Pork King Good Onion & Sour Cream Seasoning. Net Wt. 3 oz (85G) bottle....
Potential contamination with Salmonella. Product details: GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX WHITE MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk ***...
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Prostate Bully 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Blackseed Bitters 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims. Product details: Pure Shilajit Tonic 16 oz and 32 oz
Potential contamination with Salmonella. Product details: GHIRARDELLI SWEET GROUND POWDER CHOCOLATE & COCOA NET WT 48oz (3lbs) 1.36kg Distributed by Ghirardelli Chocolate Company, San...
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns. Product details: Liposomal Mens 50+ Liquid...
potential to be contaminated with Salmonella Product details: Solina 6022487 Garlic Herb Topping, 50lb bag
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Product details: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by:...
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. Product details: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by:...
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood...
Certain lots of product have the potential for a sterile barrier breach. Product details: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary...
Certain lots of product have the potential for a sterile barrier breach. Product details: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T;...
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood...
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control...
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which...
Due to stain present on the surface of affected foley catheters. Product details: Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic...
Affected devices exhibited fractures at the distal shaft tip without complete detachment. Product details: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1)...
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may...
Undeclared Yellow #5 Product details: Banana Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00903
Undeclared Milk, Soy, Red #40. Product details: Loard's Peppermint Ice Cream - 32 oz; 56 oz
Potential contamination with Salmonella. Product details: Low Heat Non-Fat Dried Milk Powder - paper bags 25 kg. (packed under 5 labels: Off Grade NFDM Variable; Extra Grade NFDM Standard...
Multi-state outbreak of E. coli O157:H7. Product details: RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP...
Package integrity compromised. Product details: Horizon Organic Chocolate Organic Lowfat Milk. Saleable Unit UPC: 742365004322 (6-8 FL OZ Milk Boxes). Case: ORG MILK 1% DHA CHOCOLATE 3/6PK...
Potential contamination with foreign materials. Product details: LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb) 907 g Manufactured and Distributed by: Lundberg Family Farms...
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Undeclared Milk, Red #40. Product details: Loard's Champagne Sherbert - 32 oz
Potential contamination with Salmonella. Product details: Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs. (packed under 5 labels: Off Grade NFDM Variable; Grade A NFDM...
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella. Product details: Costco Service Deli Department...
Product has the potential to be contaminated with Salmonella. Product details: Bulk WN-976-782-1 Seasoning for Cheese Sauce, Net Wt. 43.50 lbs., in a brown kraft bag
Incorrect Product Formulation: product did not contain insulin as listed in the label. Product details: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Product details:...
Chemical contamination; presence of lead and lithium above specification Product details: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by:...
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test Product details: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Product details:...
Subpotent drug Product details: busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201...
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Product details: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by...
Presence of Particulate Matter. Product details: Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Lack of Assurance of Sterility: Potential leaks from perforations in bags. Product details: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Product details:...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD....
Product may contain foreign objects, specifically glass. Product details: Alain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars
Contains undeclared allergens (cashews, milk, and soy). Product details: Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix, 11 oz Net Wt, packed in clear tamper resistant plastic...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produced in Winner, SD. Packaged...
Salmonella Product details: Pure Ground Ingredients-Organic Peppermint Leaf Powder. wholesale bulk; tea/food manufacturers. Closed container stored in a cool settings at ambient/room...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company the Honey Flight. 4 Flavors of Spreadable Spun Honey Original - Salted Caramel -...
Contains undeclared Blue 1 Product details: Swad Mango Flavored Masala Candy
Undeclared allergens (wheat and soy). Product details: Frederik's by meijer Vanilla Bourbon Trail Mix, packed in plastic retail-sized black bag NET WT 9 OZ (255g). On the back of the bag...
Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella. Product...
Products contain undeclared soy, specifically soy lecithin. Product details: Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, brown sugar,...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused. Stir before use. Produced in Winner, SD....
Contains undeclared FD&C Yellow 6 Product details: Swad Orange Flavored Masala Candy
Undeclared allergen ingredient (fish) Product details: ...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409...
Foreign object (stainless steel dust/flakes or shreds of plastic) Product details: Dakota Honey Company Spreadable Spun Honey, Original. Stir before use. Produced in Winner, SD. Packaged...
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. Product details:...
Presence of particulate matter: identified as Buprenorphine free base Product details: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured...
Failed Dissolution Specifications Product details: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd.,...
Medline has identified the presence of particulate within the fluid path of the Manifolds. Product details: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART...
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain...
Incomplete seals on sterile product Product details: BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Product details: Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog...
Incomplete seals on sterile product Product details: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Complaints have been received of systems developing loose, missing, or broken internal bolts over time. Product details: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers:...
Potential for mislabeled syringe produced by the i.v.STATION device. Product details: Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE,...
Incomplete seals on sterile product Product details: Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain...
Medline has identified the presence of particulate within the fluid path of the Manifolds. Product details: Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107;...
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to...
Incomplete seals on sterile product Product details: BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product Product details: Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. Product details: Similasan, iVIZIA, Sterile...
Potential contamination with pesticides, haloxyfop and thiamethoxam Product details: SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC:...
Undeclared Soy (with mitigating circumstances) Product details: Chocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley...
Undeclared Milk, Wheat, Soy, Yellow #5, Green #3. Product details: Loard's Lime Sherbert - 32 oz
Undeclared Milk, Walnuts, Eggs, Wheat, Soy. Product details: Loard's Brownie Nut Fudge Ice Cream - 32 oz
Undeclared Red #40, Blue #1, Blue #2 Product details: Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909
Undeclared Milk, Eggs, Yellow #5. Product details: Loard's Lemon Chiffon Ice Cream - 32 oz
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2. Product details: Loard's Ube Ice Cream - 32 oz
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm Product details: Garland Fresh Peeled Garlic 6 oz. bag
Undeclared Red #40 Product details: Peppermint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00933
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Natural Creamed Honey, 671333101377 *These product labels may...
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Lemon Creamed Honey, 671333101353 *These product labels may...
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. Product details: Blackberry Creamed Honey 671333101308 * These product labels...
Undeclared Milk, Almonds, Soy, Sulfites. Product details: Loard's Almond Joy Ice Cream - 32 oz
Potential contamination with pesticides, haloxyfop and thiamethoxam Product details: SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT. 25 LBS. ORIGEN: ARGENTINA...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. Product details:...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. Product...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
The devices were distributed without required FDA premarket clearance or approval. Product details: One Step K in vitro diagnostic test REF: 81A4
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm. Product...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the...
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). Product details: Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module...
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging...
Undeclared hazelnut and soy lecithin. Product details: Kirkland Signature Traditional Madeleines 12 Count/net wt. 18oz., Item #2000012, UPC 000020000127. Plastic clamshell container is...
Lead level was higher than NYSAGM Standard. Product details: Spice Powder, 4 oz, Plastic Bag
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40 Product details: Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO...
Undeclared milk. Product details: Bulk Horchata Powder 3951 (100547) 1/25 HORCHATA UPC: 042743-19015-0 Item: 100547
Product may be contaminated with Salmonella. Product details: SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
Undeclared milk. Product details: EL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY...
Undeclared milk. Product details: EL MEXICANO horchata casera Instant Horchata Drink NET WT 14oz (396g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ...
Hard corn starch lumps were found in the product Product details: CHIPS AHOY! Baked Bites Brookie .22.4 oz Carton ( 2.8 oz pouch ) and 7.7 oz Carton ( 1.4 oz pouch)
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame. Product details: Booey's Dragon's Breath sauce, 15.2oz ringneck glass...
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content. Product details: Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12...
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites) Product details: Label is predominantly green with white lettering in a clear plastic clamshell...
May be temperature abused, which may result in growth of Clostridium botulinum Product details: Crab Cakes various sizes sold to food service
Contains undeclared FD&C Yellow 6 Product details: Negita Cracker- Shrimp 2.8oz
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40). Product details: 52USA brand POPPING BOBA; PASSION...
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40). Product details: 52USA brand POPPING BOBA; MANGO...
Product may contain foreign objects, specifically glass. Product details: Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz (103g); INGREDIENTS: CREAM (MILK, CREAM), FROZEN YOLK...
Undeclared allergen (almond). Product details: Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC...
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40). Product details: 52USA brand POPPING BOBA;...
Foreign object found inside retail container. Product details: My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
Product contains undeclared Yellow No. 5. Product details: Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company,...
Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14. Product details: KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 818812022208,...
product tested positive for Listeria Monocytogenes. Product details: Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep...
cGMP deviations. Product details: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. Product details: iVIZIA, Sterile Lubricant...
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
cGMP deviations. Product details: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Product details: GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl...
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. Product details: Alendronate Sodium Oral Solution, 70...
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Lack of Assurance of Sterility Product details: Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th...
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
Failed PH Specifications Product details: Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. Product details: Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35...
cGMP deviations. Product details: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Labeling: Missing Label Product details: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967....
cGMP deviations. Product details: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be...
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be...
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings....
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel...
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the...
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol...
Cyber vulnerability of BLE communication was found by CISA VDP program. Product details: WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor...
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol...
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or...
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel...
Label declares cream cheese but does not declare milk Product details: Riverence Smoked Trout Dip, net wt. 7oz. Product is perishable, refrigerated, packaged in plastic tub. Product is...
FDA analysis revealed the presence of undeclared sildenafil Product details: Blue Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage:...
Products contain banned sweetener: cyclamates. Product details: DADI NONGFU DRIED SALT CHILLI VEGETABLE(S); Ingredients: Radish, chili, roasted sesame, prickly ash, edible salt, soybean...
FDA analysis revealed the presence of undeclared sildenafil Product details: Red Bull Extreme Male Enhancement Supplement, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage:...
Products contain banned sweetener: cyclamates. Product details: Olive Skewers individually wrapped and packaged in clear plastic bag; 500g; INGREDIENTS: Olive, edible salt, white sugar,...
Potential Salmonella Contamination Product details: Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons...
FDA analysis revealed the presence of undeclared sildenafil and Tadalafil Product details: Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15...
Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame. Product details: ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep...
Contains undeclared egg, soy, and hazelnut Product details: Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. Product details: Omega-3-Acid, Ethyl Esters,...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B....
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Product details: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by:...
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B....
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Product details: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only,...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. Product details: Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy...
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots." Product details: Pantoprazole Sodium, Delayed-Release...
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Product details: Fluocinonide, USP, 0.05% Cream,...
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on...
Chemical contamination: Presence of benzene Product details: FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1...
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on...
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Product details:...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model...
Unapproved design changes to the products outside of the 510(k) clearance. Product details: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU...
Potential for detachment of a distal tip component of the device during use. Product details: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Product details:...
XXX Product details: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Product details: LSL Healthcare Wound Closure Tray,...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) CATH LAB CDS, Model Number:...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Product details: Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. Product details:...
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. Product details: LSL Healthcare, Foley Urine...