Wellness

[Mindy D]

Durisan Hand Sanitizer Recall Due to Microbial Contamination

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.

Summary

Company Announcement Date: March 24, 2021 FDA Publish Date: March 24, 2021 Product Type: Drugs Reason for Announcement:

Due to microbial contamination

Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name:

Durisan

Product Description:

Antimicrobial Hand Sanitizer

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Company Announcement

Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of the lots listed in the table below of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The issue was discovered during a routine audit focused on production scale-up during the height of the pandemic.

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

Lot Numbers

DHS030920A1-A	DHS051420A1-S
DHS030920A2-S	DHS051420A1-S
DHS030920A3-S	DHS052020B1-S
DHS031020A4-S	DHS052020C1-S
DHS031020A5-3	DHS052220B1-S
DHS031020A6-S	DHS052620B1-S
DHS031020A7-S	DHS052720C1-S
DHS031020A8-S	DHS052720D1-S
DHS031120A1-S	DHS052820B1-S
DHS031120A2-S	DHS052820C1-S
DHS031120A3-S	DHS052820D1-S
DHS031120A4-S	DHS060120A1-S
DHS031120A5-S	DHS060220A1-S

To date, no reports of adverse reactions or customer complaints have been reported related to this recall.

The product was 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.

Use of a hand sanitizer contaminated with Burkholderia cepacia complex and Ralstonia pickettii, can range from no reaction to serious infections in a person with a hand wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems. Health care professionals who use this contaminated hand sanitizer and tend to an at-risk patient, such as one with cystic fibrosis, could lead to adverse events ranging from a localized infection to lung or bloodstream infections, which could require patient hospitalization.

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 can be identified by examples of the product labels below. The product was manufactured from Feb. 1, 2020 until June 30, 2020, and distributed to selected retailers nationwide in the United States.

Durisan has provided written notification to its distributors and retailers and is alerting customers via this voluntary recall. Consumers that have the product which is being recalled are advised to destroy it immediately.

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 e-mail 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.

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Company Contact Information

Consumers: Durisan 941-351-9114

[Kachina624]

@Mindy D    Good heavens, this hand sanitizer is proving to be the most dangerous part of the pandemic.  Did you read @SeaMaiden  's thread on the subject?  I don't use much of the stuff but I'll stick with Purell. 

[Mindy D]

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@Kachina624 wrote:

@Mindy D    Good heavens, this hand sanitizer is proving to be the most dangerous part of the pandemic.  Did you read @SeaMaiden  's thread on the subject?  I don't use much of the stuff but I'll stick with Purell. 

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@Kachina624 @In the case of this hand sanitizer, it's being recalled because it is contaminated with bacteria, one species of which was the reason for the recent recall of Parodex Oral Rinse. There's an increase of recalls in lotions and beauty products that are contaminated with this bacteria. It thrives in a wet environment.  SeaMaiden posted about carcinogens in sanitizers (Valisure labs tested and found benzene) and most of the other recalls for alcohol based sanitizers have been for sanitizers containing methanol. We just received a refund card for the Cottonelle Wipes that were contaminated a few months ago. A person just has to try to keep abreast of news about recalls because there are so many of them. 

[Porcelain]

Hahaha. Your title accidentally says Durian, but the brand is Durisan. I was thinking who on Earth would buy durian scented hand sanitizer? Maybe to ensure social distancing?

[Mindy D]

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@Porcelain wrote:

Hahaha. Your title accidentally says Durian, but the brand is Durisan. I was thinking who on Earth would buy durian scented hand sanitizer? Maybe to ensure social distancing?

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@Porcelain @Kachina624 @Forgot to add that Scent Theory Soaps were recently recalled for the same bacterial contamination. Scent Theory recalled some of its soaps due to potential contamination with Burkholderia cepacia bacteria. The products affected by the Scent Theory recall, which was issued on Feb. 11, are 11-oz. bottles of its foaming hand soap in Lemon Citrus, Vanilla Coconut, Eucalyptus Mint, and Fresh Lavender. 

[Mindy D]

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@Porcelain wrote:

Hahaha. Your title accidentally says Durian, but the brand is Durisan. I was thinking who on Earth would buy durian scented hand sanitizer? Maybe to ensure social distancing?

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@Porcelain @I love your sense of humor.