The Recall Desk

FDA (Drugs) recall action 62320

Dukal Corp. recalled 2 products on 2012-09-26

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-09-26
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Drugs)··2012-09-26

    Dukal BZK Swabs Recalled for Burkholderia cepacia Contamination

    Dukal Corporation is recalling BZK Swabs, First Aid Antiseptic, due to microbial contamination with Burkholderia cepacia. The recall covers specific lots shipped since July 2009.

    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
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2012-09-26

    Dukal Recalls ZEE Antiseptic Wipes Due to Microbial Contamination

    Dukal Corp. is recalling ZEE Antiseptic Wipes due to contamination with Burkholderia cepacia. The affected products were distributed nationwide.

    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
    Category
    Distribution
    0 states