PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: November 20, 2019 Initiated: September 24, 2019 #D-0316-2020

Product Description

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).

Details

Recalling Firm
Apotex Inc.
Units Affected
1,132,453 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 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. Recalled by Apotex Inc.. Units affected: 1,132,453 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-0316-2020.