FDA-Drug2020-07-01Class II
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
Amneal Pharmaceuticals of New York, LLC
Hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Sold states
Nationwide
Affected count
N/A
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1351-2020Don't want to check this manually?
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