FDA-Drug2019-12-18Class II
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
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, 250-count bottles, NDC 53746-254-02.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0616-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief