FDA recall D-0543-2020

Product

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0.

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-0543-2020