FDA Drug Class I — Most Serious

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

Hazard

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.

Products

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 0061
Brand
Sanit Technologies, LLC dba Durisan
UPC
Lots: DHS030920A1-A, DHS030920A2-S, DHS030920A3-S, Exp. 4/9/2022; DHS031020A4-S, DHS031020A5-S, DHS031020A6-S, DHS031020A7-S, DHS031020A8-S, Exp. 4/10/2022; DHS031120A1-S, DHS031120A2-S, DHS031120A3-S, DHS031120A4-S, DHS031120A5-S, DHS031120A6-S, Exp.4/11/2022; DHS051420A1-S, Exp. 6/14/2022; DHS052020A1-S, DHS052020B1-S, DHS052020C1-S, Exp. 6/20/2022; DHS052220B1-S, Exp. 6/22/2022; DHS052620B1-S, Exp. 6/26/2022; DHS052720C1-S, DHS052720D1-S, Exp. 6/27/2022, DHS052820B1-S, DHS052820C1-S, DHS052820D1-S, Exp. 6/28/2022; DHS060120A1-S, Exp. 7/1/2022; DHS060220A1-S, DHS062220C-S, Exp. 7/22/2022

Units Affected

8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL