FDA-Drug2018-10-31Class II
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
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.
Sold states
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Affected count
13,225 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0098-2019Don't want to check this manually?
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