D-1676-2012 Class II Terminated

Recalled by Dukal Corp. — Ronkonkoma, NY

Recall Details

Product Type
Drugs
Report Date
September 26, 2012
Initiation Date
June 14, 2012
Termination Date
June 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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 Pattern

Nationwide

Code Information

Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711