FDA-Drug2019-12-11Class II

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

Sanofi-Aventis U.S. LLC
Hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

Sold states
Nationwide
Manufactured in
55 Corporate Dr, Bridgewater, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0544-2020

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