Drug product
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
D-0321-2020
Product summary
- Event
- Event 84073
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2460 cartons/3 blister cards/10 capsules each
- Official record key
drug-enforcement:D-0321-2020
Official wording
Reason: Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Code information: Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Distribution pattern: Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications