Sanofi Recalls Zantac 150 mg Tablets Due to NDMA Impurity
Sanofi-Aventis U.S. LLC is recalling Zantac 150 mg tablets nationwide because an NDMA impurity was detected in the product.
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, particularly given the presence of a known carcinogenic impurity (NDMA) in a pharmaceutical product.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Zantac 150 mg tablets, distributed by Chattem, Inc., a Sanofi Company. The recall covers all lots of the product, including NDCs 66715-9736-2, 66715-9736-3, and 66715-9736-8. The distribution pattern is nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The source text does not specify the quantity of units affected or the exact dates of distribution.
Consumers who have purchased Zantac 150 mg tablets should stop using the product and consult their healthcare provider for guidance on alternative treatments. The source text does not provide specific instructions for returning the product or a dedicated customer service contact number.
The recalled product
- Product
- Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8
- 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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