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FDARecalled Apr 17, 2024 · #D-0439-2024

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC...

Hazard

Class II — temporary health risk

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Description

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Classification: Class II Distribution: Nationwide in the USA

Product details

Product
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Type
Drugs
Manufacturer
Teva Pharmaceuticals USA, Inc
Model numbers
100044259
UPCs