Amneal Pharmaceuticals, Inc. recalls Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed
Recalled November 20, 2019 · FDA recall D-0321-2020 · Amneal Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. · FDA Class III
Units
2460 cartons/3 blister cards/10 capsules each
Sold at
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
Description
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
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
Manufacturer(s)
Amneal Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →