Drug product
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
D-0446-2026
Product summary
- Event
- Event 98275
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8376 packages
- Official record key
drug-enforcement:D-0446-2026
Official wording
Reason: Superpotent and Subpotent
Code information: Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Distribution pattern: FL, OH, PR & MS
Derived failure modes
-
Potency or specification failure
Superpotent