TOPIC: Durisan Antimicrobial Hand Sanitizer by Sanit Technologies: Recall – Due to Microbial Contamination
AUDIENCE: Consumer, Patient, Health Professional, Risk Manager, Pharmacy
ISSUE: Sanit Technologies is recalling lots of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.
Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and 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.
To date, no reports of adverse reactions or customer complaints have been reported related to this recall.
For more information about this recall, click on the red button “Read Recall” below and the FDA updates on hand sanitizers consumers should not use.
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.
RECOMMENDATION: Consumers that have the product which is being recalled are advised to destroy it immediately.
|
