Rite Aid Ranitidine Tablets Recalled for Possible 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, particularly given the potential for significant health consequences from NDMA impurity.
Plain-English summary
Apotex Inc. is recalling Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer. The recall involves 31,968 bottles of the 24-tablet sugar-free product, identified by NDC 11822-6107-4. The product was distributed nationwide by Rite Aid.
The recall was initiated due to Good Manufacturing Practice (GMP) deviations that resulted in possible contamination with the impurity N-nitrosodimethylamine (NDMA). The recall covers all lots remaining within their expiration dates.
Consumers who have purchased this product should stop using it and contact Rite Aid or their healthcare provider for further instructions.
The recalled product
- Product
- Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
- Manufacturer
- Apotex Inc.
- Hazard
- Affected units
- 31,968
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
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