Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

Recall Number: D-0544-2020

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

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8