AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal P
Recalled December 4, 2019 · FDA recall D-0524-2020 · AVKARE
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API · FDA Class II
Units
631,138 bottles
Sold at
Nationwide.
Description
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
Manufacturer(s)
AVKARE Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →