FDA recall D-0316-2020

Apotex Inc. · Class II · drug

Product

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Distribution

Nationwide

Key facts

Status: Completed
Initiation date: 2019-09-24
Report date: 2019-11-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: North York, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0316-2020