FDAFDA · Food and drugs·Recall number D-0535-2020
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
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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