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 the FDA detected the NDMA impurity 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, and the presence of NDMA impurity in a drug product constitutes a significant health hazard, aligning with the 'Severe' criteria for significant injury/property-damage reports or high-risk contamination.
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 and is being conducted 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 be found in some medications and is associated with potential health risks.
Consumers who have purchased Maximum Strength Zantac 150 mg should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatments or disposal instructions.
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: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0
- 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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