FDA-Drug2019-12-04Class II
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
AVKARE Inc.
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Sold states
Nationwide.
Affected count
631,138 bottles
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0524-2020Don't want to check this manually?
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