FDA recall D-1415-2012

Kimberly-Clark Corporation · Class II · drug

Product

Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, 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-1415-2012