Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer
With more and more companies trying to get into the hand sanitizer manufacturing business, companies need to understand that these products can become contaminated and need to be removed from the market.
Here is a notice of voluntary recall expansion of a Non-Alcohol hand sanitizer:
Sanit Technologies LLC d/b/a Durisan announces a voluntary recall expansion on April 10, 2021 of their Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired.
The reason for this recall is due to out of specification microbial contamination found during a routine audit. This hand sanitizer was contaminated with Burkholderia contaminans. This is considered to be of low severity, however a range from no reaction to possible infections in a person with hand wounds or scrapes where the bacteria can enter the bloodstream, especially in patients with compromised immune systems.
The package sizes range from an 18mL credit cards, to sizes 118, 236, 300 and 550 mL and 100mL wall mounted dispenser refills. Identification numbers as well as the lot numbers for the products with a 24-motn expiration are included on the FDA website below.
Consumers with questions regarding this recall can contact Durisan at 941-351-9114, 8:30 am – 4:30 pm Eastern time, Monday through Friday or by email at email@example.com.
For more information on this update as well as information for FDA’s MedWatch Adverse Event Reporting program, please visit the FDA’s website.
If you have any other questions regarding this update or are looking for assistance with FDA regulation for hand sanitizer manufacturing and compliance, please email mdi Consultants, Inc at firstname.lastname@example.org RE: MedWatch.