The Recall Desk
SevereFDA (Drugs)·D-0319-2020·Announced 2019-11-20

Rite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination

Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine 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 severity score under the rubric for significant potential health risks.

Plain-English summary

Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer. The recall involves 215,387 bottles of the medication, which were distributed nationwide. The specific NDC codes affected are 11822-6052-1 (50 tablets), 11822-6052-2 (65 tablets), 11822-4727-3 (95 tablets), and 11822-6051-8 (24 tablets).

The recall was initiated due to Good Manufacturing Practice (GMP) deviations that resulted in possible contamination with the impurity N-nitrosodimethylamine (NDMA). All lots remaining within their expiration dates are included in this recall.

Consumers who have purchased these products should stop using them and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
Manufacturer
Apotex Inc.
Category
Drug — Prescription/OTC Medication
Hazard
Affected units
215,387

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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