PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: November 20, 2019 Initiated: September 24, 2019 #D-0318-2020

Product Description

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).

Details

Recalling Firm
Apotex Inc.
Units Affected
162,344 bottles
Distribution
Nationwide
Location
North York, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Apotex Inc.. Units affected: 162,344 bottles.
Why was this product recalled?
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Which agency issued this recall?
This recall was issued by the FDA Drug on November 20, 2019. Severity: Moderate. Recall number: D-0318-2020.