Cool Mint Maximum Strength Zantac 150 mg recalled over manufacturing violations
- Recall date
- October 22, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Sanofi-Aventis U.S. LLC recalls Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, T…
- Recall number
- D-0538-2020
- FDA classification
- Class II
- Brand / firm
- Sanofi-Aventis U.S. LLC
- Sold / distributed
- Nationwide
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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