FDA-Drug2019-12-11Class II

Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96

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 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2020

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