AAA Pharmaceutical, Inc. recalls Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Recalled January 15, 2020 · FDA recall D-0646-2020 · AAA Pharmaceutical
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API · FDA Class II
Units
31,536 (130-count bottles)
Sold at
Product was distributed to one consignee who may have distributed the product further to their retail stores.
Description
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Manufacturer(s)
AAA Pharmaceutical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →