Regular Strength Zantac 75 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 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-021…
- Recall number
- D-0535-2020
- 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
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8
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