PlainRecalls
FDA Drug Critical Class I Terminated

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content

Reported: July 21, 2021 Initiated: March 10, 2021 #D-0656-2021

Product Description

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243

Reason for Recall

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

Details

Units Affected
8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL
Distribution
Nationwide in the USA and Bahamas
Location
Sarasota, FL

Frequently Asked Questions

What product was recalled?
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content 10 oz bottle, (UPC 8 52379 00697 4); g) 550 mL Net Content 18.59 oz bottle, (UPC 8 52379 00620 2) ; h) 1000 mL Net Content 33.81 oz kidney bottle dispensing 0.4 or 0.8 each actuation, (UPC 8 50008 48507 7 and 8 52379 00610 3); and i) 1 Gallon Net Content 128 oz bottle, (UPC 8 52379 00621 9); Sanit Technologies, LLC 7810 25th Court East, Unit 106 Sarasota, Florida 34243. Recalled by Sanit Technologies, LLC dba Durisan. Units affected: 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 21, 2021. Severity: Critical. Recall number: D-0656-2021.