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Recall

Teva Pharmaceuticals USA, Inc: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, Recall

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Product details: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., N...

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Agency
FDA
Record ID
N/A
Canonical
https://claimwatch-mvp.vercel.app/item/teva-pharmaceuticals-usa-inc-claravis-isotretinoin-capsule-usp-10-mg-packaged-as-a-100-cou/

What happened?

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Product details: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., N...

Who may be affected?

Nationwide in the USA; Virgin Islands

What should consumers do?

Affected quantity: 5,101 cartons

Official source

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