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
Recall Number: D-0536-2020
Firm: Sanofi-Aventis U.S. LLC
Classification: Class II
Status: Ongoing
Report Date: 20191211
Initiation Date: 20191022
Termination Date:
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Product Description
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