FDA-Drug2019-12-18Class II
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
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 Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0614-2020Don't want to check this manually?
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