FDA recall D-0524-2020

Product

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

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-0524-2020