Sanofi Recalls Maximum Strength Zantac 150 mg Due to NDMA Impurity
Sanofi-Aventis U.S. LLC is recalling Maximum Strength 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 FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the rubric for drug recalls involving significant health risks like NDMA impurities.
Plain-English summary
Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets, distributed by Chattem, Inc. The recall covers all lots of the product, which is available nationwide. The specific NDC codes affected are 41167-0310-1, 41167-0310-2, 41167-0310-3, 41167-0310-4, 41167-0310-6, 41167-0310-7, and 41167-0310-8.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. The FDA has classified this recall as Class II.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8
- 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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