FDA recall D-1675-2012

Dukal Corp. · Class II · drug

Product

ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA

Reason for recall

Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2012-06-14
Report date: 2012-09-26
Termination date: 2013-06-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ronkonkoma, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1675-2012