FDA recall D-0318-2020

Apotex Inc. · Class II · drug

Product

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716

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-0318-2020