Amneal Pharmaceuticals, Inc. recalls Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180
Recalled December 18, 2019 · FDA recall D-0612-2020 · 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 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).
Manufacturer(s)
Amneal Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →