Drug product
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
D-0445-2026
Product summary
- Event
- Event 98275
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21984 packages
- Official record key
drug-enforcement:D-0445-2026
Official wording
Reason: Superpotent and Subpotent
Code information: Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
Distribution pattern: FL, OH, PR & MS
Derived failure modes
-
Potency or specification failure
Superpotent