FDA recall D-0525-2020

AVKARE Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2019-11-14
Report date: 2019-12-04
Termination date: 2021-10-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2020