Recall
Liebel-Flarsheim Company LLC: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile So Recall
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. Product details: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
What happened?
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. Product details: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
Who may be affected?
Distributed Nationwide in the US and Mexico.
What should consumers do?
Affected quantity: 3,486 500mL-vials
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