Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60

Recall Number: D-0098-2019

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.

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60