The Recall Desk
SevereFDA (Drugs)·D-0318-2020·Announced 2019-11-20

Apotex Recalls Equate Ranitidine Tablets Due to NDMA Contamination

Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets due to possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers 162,344 bottles distributed nationwide.

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 agency classification is FDA Class II, and the presence of NDMA, a potential carcinogen, in a drug product constitutes a significant health risk warranting a Severe rating under the rubric.

Plain-English summary

Apotex Inc. is recalling Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free, 65 Tablets (NDC: 49035-117-06). The product is distributed by Wal-Mart Stores, Inc. The recall involves 162,344 bottles that were distributed nationwide.

The recall was initiated due to Good Manufacturing Practice (GMP) deviations that resulted in possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall includes all lots remaining within their expiry dates.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
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
Manufacturer
Apotex Inc.
Category
Drug — Oral Solid Dosage
Hazard
Affected units
162,344

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 →

Related recalls

Same manufacturer · Apotex Inc.

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Same hazard · ndma contamination

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