Dukal Benzalkonium Chloride Antiseptic Wipes Recalled due to Potential Contamination with Burkholderia Cepacia

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The FDA informs consumers, Pharmacy personnel that Dukal Benzalkonium Chloride Antiseptic Wipes and Swabs are recalled because there is the possibility of microbial contamination with Burkholderia cepacia which can lead to infections.

Background of Dukal Benzalkonium Chloride Antiseptic Wipes

Dukal Benzalkonium Chloride Antiseptic Wipes, by Jianerkang Medical Dressing Co., are sold separately over-the-counter and in kits. The distribution of the products is nationwide to wholesalers and retailers.

FDA Alert on Dukal Benzalkonium Chloride Antiseptic Wipes

FDA’s reason for the recall is that there are concerns that Dukal Benzalkonium Chloride Antiseptic Wipes and Swabs can potentially be contaminated with Burkholderia cepacia. This can lead to infections and certain health risks in patients which are immune-suppressed.

Recommendation on Dukal Benzalkonium Chloride Antiseptic Wipes

“All customers are advised to discontinue use of products identified in this recall immediately and should dispose of the product. See the Press Release for a listing of lot numbers affected by this recall.”

Contacting the FDA to report cases with Dukal Benzalkonium Chloride Antiseptic Wipes

In case of detection of adverse events or side effects related to the use of Dukal Benzalkonium Chloride Antiseptic Wipes, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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