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

Recall Number: D-0439-2024

Firm: Teva Pharmaceuticals USA, Inc

Classification: Class II

Status: Ongoing

Report Date: 20240417

Initiation Date: 20240328

Termination Date:

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

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