FDA recall D-0538-2020

Sanofi-Aventis U.S. LLC · Class II · drug

Product

Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2019-10-22
Report date: 2019-12-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0538-2020