FDA-Drug2019-11-06Class II
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
AVKARE Inc.
Hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Sold states
CO, MO
Affected count
1351 bottles
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2020Don't want to check this manually?
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