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 Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9…
- Recall number
- D-0544-2020
- 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
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
Get recall alerts
Free email alert whenever Sanofi-Aventis U.S. LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Sanofi-Aventis U.S. LLC