FDA MedWatch - Durisan Non Alcohol Antimicrobial Hand Sanitizer Products by Sanit Technologies:

Recall - Addition of Label Clarification to Existing Hand Sanitizer Recall

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Durisan Non Alcohol Antimicrobial Hand Sanitizer Products by Sanit Technologies: Recall - Addition of Label Clarification to Existing Hand Sanitizer Recall AUDIENCE: Consumer, Health Professional ISSUE: Sanit Technologies LLC d/b/a Durisan, is providing an additional 5 label illustrations and product sizes for customers that might not have been able to clearly identify containers of Non-Alcohol Hand Sanitizer products that were added to the voluntary recall initiated on March 24, 2021, and expanded by the April 10 and May 14, 2021 notices.  Durisan Non Alcohol Antimicrobial Hand Sanitizer products 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. 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: Durisan Non Alcohol Antimicrobial 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 in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with the lot numbers of the recalled products are encouraged 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 drug 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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