Benzalkonium Chloride Antiseptic Wipes by Dukal: Recall – Potential Microbial Contamination

AUDIENCE: Consumer, Pharmacy

ISSUE: 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. This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. Use of contaminated wipes could lead to infections, some of which pose health risks in immune-suppressed patients.

BACKGROUND: Benzalkonium chloride antiseptic wipes are sold separately over-the counter and in kits. These products were distributed nationwide to the wholesale and retail levels.

RECOMMENDATION: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178