The Recall Desk
SevereFDA (Drugs)·D-0314-2020·Announced 2019-11-20

Apotex Recalls Walgreens Wal-Zan 150 Tablets Due to NDMA Contamination Risk

Apotex Inc. is recalling Walgreens Maximum Strength Wal-Zan 150 tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA).

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant health risks associated with NDMA impurities.

Plain-English summary

Apotex Inc. is voluntarily recalling Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer. The recall involves 259,647 bottles distributed nationwide in various package sizes, including 200, 24, 95, and 65 tablets. The recall is being conducted due to Good Manufacturing Practice (GMP) deviations that resulted in possible contamination with the impurity N-nitrosodimethylamine (NDMA).

The affected product is identified by NDC numbers 0363-1030-07, 0363-1030-02, 0363-1030-09, and 0363-1030-06. All lots remaining within their expiration dates are included in this recall. The product was distributed by Walgreen Co. in Deerfield, IL.

Consumers who have purchased these specific tablets should stop using them and contact their healthcare provider or pharmacist for guidance on alternative acid reducer options. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

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
Manufacturer
Apotex Inc.
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
259,647

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Apotex Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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Same hazard · ndma contamination

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