FDA recall D-0545-2020

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

Product

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

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-0545-2020