amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
Recall Number: D-1350-2020
Firm: Amneal Pharmaceuticals of New York, LLC
Classification: Class II
Status: Ongoing
Report Date: 20200701
Initiation Date: 20200529
Termination Date:
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product Description
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK