FDAClass IINovember 20, 2019

Walgreens Maximum Strength Wal-Zan 150 Ranitidine recall: Nitrosamine Impurity

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

Why was Walgreens Maximum Strength Wal-Zan 150 Ranitidine recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots remaining within expiry.

Product
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
Recalling firm
Apotex Inc.
Quantity
259,647 bottles
Distribution
Nationwide
Recall date
November 20, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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