FDA recall D-1414-2012

Kimberly-Clark Corporation · Class II · drug

Product

Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076

Reason for recall

Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.

Distribution

Nationwide and Canada

Key facts

Status: Terminated
Initiation date: 2012-06-14
Report date: 2012-07-18
Termination date: 2013-04-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Roswell, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1414-2012