Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
Recall Number: D-0540-2020
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
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.