Granules India Limited recalls RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Recalled January 8, 2020 · FDA recall D-0632-2020 · Granules India
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API · FDA Class II
Units
23,090,000 tablets
Sold at
OR, NY, NJ
Description
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Manufacturer(s)
Granules India Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →