Durisan Antimicrobial Hand Sanitizer in several package sizes is being voluntarily recalled for possible microbial contamination. The recall was issued because of out of specification results of bacterial counts for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit that was focused on production scale-up during the height of the coronavirus pandemic. No reports of adverse reactions or consumer complaints have been received by the company to date.
The Durisan Antimicrobial Hand Sanitizer was packaged in sizes that ranged from 18 mL credit cards, to bottles that were sized 118 mL, 236 mL, 300 mL, and 500 mL. It was also available in 1000 mL wall mounted dispenser refills. You can see pictures of recalled product labels at the FDA web site, along with UPC numbers, NDC numbers, and lot numbers.
This product is supposed to be applied topically to help reduce bacteria on the skin when soap and water aren’t available. The hand sanitizer was manufactured from February 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.
Use of a hand sanitizer that is contaminated with those pathogen species can range from no infection to serious infection in a person who has hand wounds and scrapes. The bacteria could enter the bloodstream, especially in people who have compromised immune systems. Any health care professional who uses this product and tends to an at-risk patient could cause adverse events that may range from localized infection to lung or bloodstream infections.
If you purchased these hand sanitizer products, do not use. Throw it away after first double bagging it in a secure garbage can. Or you can contact the company to arrange for a refund.
Any adverse events relating to these products should be reported to the FDA. You can use The FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax.
