Product: Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Reason for recall: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated: 20200602
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated