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Registered: ‎05-23-2010

Non alcohol Durisan hand sanitizer recall. Possible contamination with Burkholderia contaminants

Summary

Company Announcement Date: April 10, 2021 FDA Publish Date: April 16, 2021 Product Type: Drugs Reason for Announcement:
Product is contaminated with Burkholderia contaminans
Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name:
Durisan
Product Description:
Hand sanitizer

Company Announcement

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. 

Durisan Antimicrobial Solutions Hand Sanitizer Sizes With the Following Identification
Volume mLVolume oz.UPCNDC
180.618 52379 00614 171120-112-01
11848 52379 00634 971120-112-10
23688 52379 00635 671120-112-11
300108 52379 00697 471120-112-08
55018.598 52379 00620 271120-112-06
100033.818 52379 00610 371120-112-05

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 customerservice@durisan.com.

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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Lot Numbers of Recalled Products
DHS041519A1-S
DHS041519A2-S
DHS041519A3-S
DHS041519A4-S
DHS041519A5-S
DHS041519A6-S
DHS042919AR1-S
DHS043019AR1-S
DHS053019A1-S
DHS053019A2-S
DHS053019A4-S
DHS053019A5-S
DHS053019A6-S
DHS070219A1-S
DHS070219A2-S
DHS070219A3-S
DHS070219A5-S
DHS070219A6-S
DHS080219A1-S
DHS091819A1-S
DHS030920A1-A
DHS030920A2-S
DHS030920A3-S
DHS031020A4-S
DHS031020A5-S
DHS031020A6-S
DHS031020A7-S
DHS031020A8-S
DHS031120A1-S
DHS031120A2-S
DHS031120A3-S
DHS031120A4-S
DHS031120A5-S
DHS031120A6-S
DHS051420A1-S
DHS052020A1-S
DHS052020B1-S
DHS052020C1-S
DHS052220B1-S
DHS052620B1-S
DHS052720C1-S
DHS052720D1-S
DHS052820B1-S
DHS052820C1-S
DHS052820D1-S
DHS060120A1-S
DHS060220A1-S

Source: Sanit Technologies

Link to Initial Release

 


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