Drug recall D-0321-2020
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
Reason for recall
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Lots and codes
Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
Recall details
- Recalling firm
- Amneal Pharmaceuticals, Inc., Brookhaven, NY
- Quantity
- 2460 cartons/3 blister cards/10 capsules each
- Distribution
- Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 16, 2019
- Terminated
- November 9, 2020
Related products
- Isotretinoin – drug information
- NDC 69238-1174 Isotretinoin · Isotretinoin 10 mg/1 · Amneal Pharmaceuticals LLC
- NDC 69238-1176 Isotretinoin · Isotretinoin 40 mg/1 · Amneal Pharmaceuticals LLC
- NDC 69238-1017 Isotretinoin · Isotretinoin 30 mg/1 · Amneal Pharmaceuticals LLC
- NDC 69238-1175 Isotretinoin · Isotretinoin 20 mg/1 · Amneal Pharmaceuticals LLC