Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
Sanofi-Aventis U.S. LLC is recalling Cool Mint Maximum Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected.
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 and involves the detection of NDMA, a known carcinogen, which aligns with the rubric criterion for Severe severity (FDA Class II with significant health risk).
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Cool Mint Maximum Strength Zantac 150 mg tablets, distributed by Chattem, Inc. The recall covers all lots of the product, identified by NDCs 41167-0320-1 through 41167-0320-7. The product was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. NDMA is a chemical that can cause cancer in animals and may increase the risk of cancer in humans.
Consumers who have purchased this product should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Hazard
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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Sanofi-Aventis U.S. LLC 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.
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