D-0321-2020 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 20, 2019
- Initiation Date
- October 16, 2019
- Termination Date
- November 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2460 cartons/3 blister cards/10 capsules each
Product Description
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.
Distribution Pattern
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Code Information
Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019