Class III
Terminated
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
- Company
- Amneal Pharmaceuticals, Inc.
- Recall Initiated
- October 16, 2019
- Posted
- November 20, 2019
- Recall Number
- D-0321-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2460 cartons/3 blister cards/10 capsules each
- Firm Location
- Brookhaven, NY, United States
Reason for Recall
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Distribution
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Lot / Code Info
Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
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