Teva Pharmaceuticals USA recalls Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laborator
Recalled October 31, 2018 · FDA recall D-0098-2019 · Teva Pharmaceuticals USA
Hazard
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. · FDA Class II
Units
13,225 bottles
Sold at
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Description
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Product
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
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →