FDAFDA · Food and drugs·Recall number D-0536-2020
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
Published December 11, 2019 · Recall initiated: October 22, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of NDMA impurity detected in product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sanofi-Aventis U.S. LLC
- Distributor
- Nationwide
- Lot
- all lots
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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