Teva Pharmaceuticals USA Inc recalls Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratori
Recalled March 15, 2023 · FDA recall D-0441-2023 · Teva Pharmaceuticals USA
Hazard
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. · FDA Class II
Units
12,044 Bottles
Sold at
CA
Description
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Product
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
Manufacturer(s)
Teva Pharmaceuticals USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →