PlainRecalls
FDA Drug Moderate Class II Completed

Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06

Reported: November 20, 2019 Initiated: September 24, 2019 #D-0314-2020

Product Description

Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06

Reason for Recall

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

Details

Recalling Firm
Apotex Inc.
Units Affected
259,647 bottles
Distribution
Nationwide
Location
North York, N/A

Frequently Asked Questions

What product was recalled?
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06. Recalled by Apotex Inc.. Units affected: 259,647 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-0314-2020.