FDA-Drug2020-06-24Class II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) 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
1,586,913 bottles
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1305-2020Don't want to check this manually?
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