Drug 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
D-0439-2024
Product summary
- Event
- Event 94294
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,304 3x10-cartons
- Official record key
drug-enforcement:D-0439-2024
Official wording
Reason: Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Code information: Lot #: 100044259, Exp 06/30/2025.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent