FDA-Drug2019-12-18Class II
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
Amneal Pharmaceuticals, Inc.
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Sold states
Product was distributed throughout the United States.
Affected count
N/A
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0613-2020Don't want to check this manually?
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