OTC DRUG Nationwide Recall –Important Information AboutBenzalkonium Chloride Antiseptic Wipes

Today, DUKAL Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for DUKAL by Jianerkang Medical Dressing Co. Benzalkonium chloride antiseptic wipes are sold separately over-the counter and in kits.
This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. All customers are advised to discontinue use of products identified in this recall immediately as their use could lead to infections, some of which pose certain health risks in immune-suppressed patients. For average healthy people, the presence of Burkholderia cepacia on the swab is not likely to cause serious health risks.
To date, there have been no reported incidents involving these products. In an abundance of caution, we are voluntarily recalling these products to prevent any such potential risk. All customers should dispose of the product. All distributors and kit packers, who include benzalkonium chloride swabs or antiseptic wipes as a component in their kits, should discontinue use of the product and initiate a sub-recall to their customers. All distributors and kit packers should return product in their inventories to DUKAL. These products were distributed nationwide to the wholesale and retail levels.
DUKAL is deeply committed to providing high quality, reliable products and issues this recall as a precaution to ensure consumer safety. DUKAL continues to work closely with FDA to ensure our products meet or exceed FDA requirements.

Instructions

This voluntary recall is for the following BZK product lot numbers:

This voluntary recall is for BZK products still within product expiration date.
For more information, regarding this voluntary recall and whether to dispose of or return the product, the customer support team can be reached Monday to Friday from 8:30 am to 5:30 pm Eastern time at 800.243.0741. Emails may be sent to [email protected].
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s Med Watch Adverse Events Program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.