Sanit Technologies, LLC dba Durisan: Drug Recall

Recall #D-0656-2021 · 03/10/2021

Class I: Dangerous

Recall Details

Recall Number
D-0656-2021
Classification
Class I
Product Type
Drug
Recalling Firm
Sanit Technologies, LLC dba Durisan
Status
Terminated
Date Initiated
03/10/2021
Location
Sarasota, FL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL

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.

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

Distribution Pattern

Nationwide in the USA and Bahamas

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.