Washington, D.C.–The U.S. Food and Drug Administration (FDA) is warning consumers and health care professionals not to use Durisan Antimicrobial Solutions Hand Sanitizer manufactured by Sanit Technologies, LLC in Sarasota, Florida, due to microbial contamination. Durisan has voluntarily recalled its hand sanitizer product.
Durisan tested its hand sanitizer and found microbial contamination including high levels of Burkholderia cepacia complex and Ralstonia pickettii, which can lead to serious infections, including infection of the skin, soft tissues, lungs or bloodstream.
Individuals with compromised immune systems are at increased risk. Infection can occur with use of the contaminated hand sanitizer by consumers or by health care professionals who may also transmit the contaminating bacteria to patients. Use of this contaminated hand sanitizer by health care professionals who tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization or extend an existing hospitalization.
The agency has updated its do-not-use list of hand sanitizers to include Durisan’s contaminated hand sanitizers.
Durisan’s hand sanitizer, which contains benzalkonium chloride as an active ingredient, is available online and in retail stores. Consumers who have products on the list of hand sanitizers with potential contamination should immediately stop using the product and dispose of it, ideally in a hazardous waste container. Do not pour these products down the drain or flush them. Contact your local waste management and recycling center for more information on hazardous waste disposal.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol (also referred to as ethyl alcohol).
FDA is not aware of any adverse events related to Durisan’s hand sanitizer products. They encourage health care professionals, consumers, and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program. https://www.accessdata.fda.gov/scripts/medwatch/index.cfm