Durisan Hand sanitizer - recalled due to Burkholderia contaminans contamination, USA

United States

Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Hand sanitizer
Reason of the recall: Product is contaminated with Burkholderia contaminants
FDA Recall date: May 17, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan is updating its previously announced voluntary recall of Durisan Non-Alcohol Antimicrobial Hand Sanitizer products that became contaminated with a common municipal water supply-borne bacteria, Burkholderia contaminants. Use of a hand sanitizer contaminated with Burkholderia contaminants, 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.

In the April 10, 2021 announcement, Durisan expanded the recall to include all of its Hand Sanitizer products that had not expired (produced after 4/10/2019). Durisan discovered that promotional orders, as well as small run production lot numbers which were not listed, were intended for inclusion in the recall. For clarification, in the link below are all affected lot numbers.

Customers or consumers in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with these numbers in any form factor are encouraged to contact Durisan. To date, no qualified reports of adverse reactions have been reported related to this recall. 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.

The product is packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. At this time, we are including lot numbers of promotional orders, wipes, and private label products. The lot number can be found in black print on the bottom of the package. Durisan Antimicrobial Solutions hand sanitizer sizes with the identification are listed in the link below.

Durisan has provided written notification to its distributors and retailers and is alerting consumers via this voluntary recall. Consumers that have the product are advised to contact Durisan to return it. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-expansion-durisan-non-alcohol-hand-sanitizer

Source: FDA