FDA MedWatch - Non-Alcohol Hand Sanitizer by Durisan:

Recall Expansion - Due to Possible Microbial Contamination with Burkholderia contaminans

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Non-Alcohol 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 is updating its previously announced recall of Durisan Non Alcohol Antimicrobial Hand Sanitizer products that became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. 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. 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.   To date, no qualified reports of adverse reactions have been reported related to this recall. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Non-alcohol hand sanitizer products are 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 product. Consumers and health professionals 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.

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