FDA recall D-0165-2020

AVKARE Inc. · Class II · drug

Product

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Distribution

CO, MO

Key facts

Status: Terminated
Initiation date: 2019-10-17
Report date: 2019-11-06
Termination date: 2020-10-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2020