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COMPANY ANNOUNCEMENT

Recall Expansion of Durisan Non-Alcohol Hand Sanitizer

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Contaminants
Reason for Announcement:
Recall Reason Description
Product is contaminated with Burkholderia contaminans
Company Name:
Sanit Technologies LLC d/b/a Durisan
Brand Name:
Brand Name(s)
Durisan
Product Description:
Product Description
Hand sanitizer

Company Announcement

Sanit Technologies LLC d/b/a Durisan is updating its previously announced voluntary 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. For clarification, listed below are all affected lot numbers. Customers or consumers in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with these numbers in any form factor are encouraged to contact Durisan.

To date, no qualified reports of adverse reactions 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.

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. At this time, we are including lot numbers of promotional orders, wipes, and private label products. The lot number can be found in black print on the bottom of the package.

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
500 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
160 (160 Ct Wipe) 5.63 8 52379 00631 8 71120-111-01
80 (80 Ct Wipe) 2.81 8 52379 00632 5 71120-111-02
240 (240 Ct Wipe) 8.44 8 52379 00633 2 71120-111-03

The list of the lot numbers of the recalled products is included below.

Durisan has provided written notification to its distributors and retailers and is alerting consumers 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.

  • 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 DHS051420A1-S
DHS041519A1-S DHS051520A1R1-S
DHS041519A2-S DHS052020A1-S
DHS041519A3-S DHS052020A1R1-S
DHS041519A4-S DHS052020B1-S
DHS041519A5-S DHS052020B1R1-S
DHS041519A6-S DHS052020C1-S
DHS042919AR1-S DHS052020CR1-S
DHS043019AR1-S DHS052220A1R1-S
DHS050319A4-S DHS052220B1-S
DHS053019A1-S DHS052620B1-S
DHS053019A2-S DHS052720C1-S
DHS053019A4-S DHS052720C1R1-S
DHS053019A5-S DHS052720D1-S
DHS053019A6-S DHS052820B1-S
DHS070219A1-S DHS052820C1-S
DHS070219A2-S DHS052820D1-S
DHS070219A3-S DHS052920A1R1-S
DHS070219A4-S DHS052920B1R1-S
DHS070219A5-S DHS052920C1R1-S
DHS070219A6-S DHS060120A1-S
DHS070219AB-S DHS060220A1-S
DHS080219A1-S DHS060320C1R1-S
DHS091819A1-S DHS060520C1R1-S
DHS030920A1-S DHS060520F1R1-S
DHS030920A2-S DHS060820E1R1-S
DHS030920A3-S DHS061220A1R1-S
DHS031020A4-S DHS061920B1R1-S
DHS031020A5-S DHS062220C-S
DHS031020A6-S DHS062320B1R1-S
DHS031020A7-S DHS062420B1R1-S
DHS031020A8-S DHS081120A1-S
DHS031120A1-S DHS081220A1R1-S
DHS031120A2-S DHS081420B1-S
DHS031120A3-S DHS081420B3-S
DHS031120A4-S DHS081420B6-S
DHS031120A5-S DHS081420B8-S
DHS031120A6-S DHS081720A3-S
DHS032820B1-S DHS081720A5-S

Source: Sanit Technologies

Original Source:  www.newswire.com

April 2021 Expansion

Original Press Release

 


Company Contact Information

Consumers:
Durisan
941-351-9114
customerservice@durisan.com
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