Recall: D-0439-2024

Class II - Potentially Harmful

Class IIClassification

2024-03-28Initiated

OngoingStatus

Teva Pharmaceuticals USA, IncFirm

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

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.