FDA-Drug2020-06-24Class II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
Apotex Inc.
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Sold states
Nationwide.
Affected count
305,963 bottles
Manufactured in
150 Signet Drive, North York, Canada
Products
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1303-2020Don't want to check this manually?
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