Sanofi-Aventis U.S. LLC recalls Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, C
Recalled December 11, 2019 · FDA recall D-0534-2020 · 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
Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.
Manufacturer(s)
Sanofi-Aventis U.S. LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →