Product: amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807   NDC 65162-178-10
Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated: 20200529
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated