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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

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
Recall Number D-1676-2012
Classification Class II
Code Info Antiseptic wipes shipped since July 02, 2009. Lots: JT34808, JT08209, JT15209, JT32809, JT00610, JT27610, JT05311, JT18211, JT22711-1, JT26411, JT01012, JT00610, JT14511, JT22011, JT30711
Product Distributed Qty
Reason For Recall Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

Event Detail

Event Id 62320
Product Type Drugs
Status Ongoing
Recalling Firm Dukal Corp.
City Ronkonkoma
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-14
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide