FDA-Drug2019-12-04Class II
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
AVKARE Inc.
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Sold states
Nationwide.
Affected count
104,797 bottles
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2020Don't want to check this manually?
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