FDA MedWatch – Antimicrobial Hand Sanitizer by Durisan:

TOPIC: Antimicrobial Hand Sanitizer by Durisan: Recall Expansion – Due to Possible Microbial Contamination with Burkholderia contaminans

AUDIENCE: Consumer, Health Professional

ISSUE: Sanit Technologies LLC d/b/a Durisan announced a recall expansion of its Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired. The products are being recalled due to out of specification microbial contamination. The issue was discovered during a routine audit.

To date, no reports of adverse reactions or customer complaints have been reported related to this recall.

Use of a hand sanitizer contaminated with Burkholderia contaminans, generally considered to be of low virulence, can range from no reaction to possible infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available.

RECOMMENDATIONS: 

• Consumers that have the product are advised to contact Durisan to return it.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Health 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.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.