Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Recalled December 18, 2019 · FDA recall D-0616-2020 · Amneal Pharmaceuticals
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API · FDA Class II
Units
N/A
Sold at
Product was distributed throughout the United States.
Description
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Manufacturer(s)
Amneal Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →