FDA-Drug2020-06-24Class II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
AVKARE Inc.
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Sold states
Nationwide.
Affected count
88,545 bottles
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1304-2020Don't want to check this manually?
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