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Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, ...

FDA Drug Recall #D-0656-2021 — Class I — March 10, 2021

Recall Summary

Recall Number D-0656-2021
Classification Class I — Serious risk
Date Initiated March 10, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sanit Technologies, LLC dba Durisan
Location Sarasota, FL
Product Type Drugs
Quantity 8,609,863 credit card size containers, 665,395 bottles, and 70,462 kidney bottles TOTAL

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.

Distribution Pattern

Nationwide in the USA and Bahamas

Lot / Code Information

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

Other Recalls from Sanit Technologies, LLC dba Durisan

Recall # Classification Product Date
D-0657-2021 Class I Durisan Antimicrobial Solutions (benzalkonium c... Mar 10, 2021
D-0658-2021 Class II Durisan Antimicrobial Solutions (benzalkonium c... Mar 10, 2021
D-0659-2021 Class II Durisan Antimicrobial Solutions (benzalkonium c... Mar 10, 2021

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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