FDA Recall D-0656-2021

Sanit Technologies, LLC dba Durisan · Sarasota, FL

Class I — life-threatening Terminated 315 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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

Lot / code: 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

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.

Recall record

Recall number: D-0656-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and Bahamas
Recall initiated: 2021-03-10
Classified by FDA Center: 2021-07-13
FDA published: 2021-07-21
Terminated: 2022-01-19
Recalling firm: Sanit Technologies, LLC dba Durisan
Firm location: Sarasota, FL

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