FDA-Drug2018-10-31Class II
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
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
3,397 bottles
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0099-2019Don't want to check this manually?
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