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

Recall Number: D-0321-2020

Firm: Amneal Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20191120

Initiation Date: 20191016

Termination Date: 20201109

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

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