Product: Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.
Reason for recall: CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated: 20191022
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated