FDA-Drug2023-03-15Class II
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Teva Pharmaceuticals USA Inc
Hazard
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Sold states
CA
Affected count
12,044 Bottles
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2023Don't want to check this manually?
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