Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01

Recall Number: D-0099-2019

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20181031

Initiation Date: 20180806

Termination Date: 20200213

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01