Sanofi-Aventis U.S. LLC recalls Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219
Recalled December 11, 2019 · FDA recall D-0537-2020 · Sanofi-Aventis U.S
Hazard
CGMP Deviations: Presence of NDMA impurity detected in product. · FDA Class II
Sold at
Nationwide
Description
CGMP Deviations: Presence of NDMA impurity detected in product.
Product
Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25.
Manufacturer(s)
Sanofi-Aventis U.S. LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →