- Company Announcement Date:
- April 10, 2021
- FDA Publish Date:
- April 16, 2021
- Product Type:
- Reason for Announcement:
Recall Reason Description
Product is contaminated with Burkholderia contaminans
- Company Name:
- Sanit Technologies LLC d/b/a Durisan
- Brand Name:
- Product Description:
Sanit Technologies LLC d/b/a Durisan announces a voluntary recall expansion of its Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired. The products are being recalled due to out of specification microbial contamination. The issue was discovered during a routine audit.
To date, no reports of adverse reactions or customer complaints 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.
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.
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. Pictures are available in the attached related file.
Durisan Antimicrobial Solutions Hand Sanitizer Sizes With the Following Identification
|Volume mL||Volume oz.||UPC||NDC|
|18||0.61||8 52379 00614 1||71120-112-01|
|118||4||8 52379 00634 9||71120-112-10|
|236||8||8 52379 00635 6||71120-112-11|
|300||10||8 52379 00697 4||71120-112-08|
|550||18.59||8 52379 00620 2||71120-112-06|
|1000||33.81||8 52379 00610 3||71120-112-05|
The list of the lot numbers of the subject products, which have a 24-month expiration, is included below.
Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product are advised to contact Durisan to return it.
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 protected].
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Lot Numbers of Recalled Products
Source: Sanit Technologies
Link to Initial Release