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.
Recall initiated: 20191016
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated