FDA-Drug2019-12-11Class II

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02

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
Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2020

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