FDA recall D-1676-2012

Dukal Corp. · Class II · drug

Product

Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031

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-1676-2012