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

Recall Number: D-1331-2020

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20200701

Initiation Date: 20200602

Termination Date: 20240412

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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