Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected. This action addresses current good manufacturing practice (CGMP) deviations.
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. The presence of NDMA impurity represents a significant health risk, justifying a score of 4.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets (NDC 67751-151-01). The product is distributed by Chattem, Inc., a Sanofi Company, and is available nationwide. The recall covers all lots of the affected product.
The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the presence of the NDMA impurity was detected in the product. NDMA is a chemical substance that has been associated with potential health risks.
Consumers who have purchased this product should stop using it and contact their healthcare provider or pharmacist for guidance. The source text does not specify a particular return address or refund process, but the recall is active for all lots of the identified NDC.
The recalled product
- Product
- Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01.
- Manufacturer
- Sanofi-Aventis U.S. LLC
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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