🔍 RecallPedia

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243.

Class I - Dangerous
💊 Drugs Recalled: March 10, 2021 Sanit Technologies, LLC Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    DHS041519A1-S, DHS041519A2-S, DHS041519A3-S, DHS041519A4-S, DHS041519A5-S, DHS041519A6-S, Exp. 5/15/2021; DHS042919AR1-S, Exp. 5/29/2021; DHS043019AR1-S, Exp. 5/30/2021; DHS050319A4-S, Exp. 6/03/2021; DHS053019A1-S, DHS053019A2-S, DHS053019A4-S, DHS053019A5-S, DHS053019A6-S, Exp. 6/30/2021; DHS070219A1-S, DHS070219A2-S, DHS070219A3-S, DHS070219A4-S, DHS070219A5-S, DHS070219A6-S, DHS070219AB-S, Exp. 8/2/2021; DHS080219A1-S, Exp. 9/2/2021; DHS091819A1-S, Exp 10/18/2021; DHS032820B1-S, Exp 4/28/2022; DHS051520A1R1-S, Exp. 6/15/2022; DHS052020A1R1-S, DHS052020B1R1-S, DHS052020CR1-S, Exp. 6/20/2022; DHS052220A1R1-S, Exp. 6/22/2022; DHS052720C1R1-S, Exp 6/27/2022; DHS052920A1R1-S, DHS052920B1R1-S, DHS052920C1R1-S, Exp 6/29/2022; DHS060320C1R1-S, Exp. 7/3/2022; DHS060520C1R1-S, DHS060520F1R1-S, Exp. 7/5/2022; DHS060820E1R1-S, Exp. 7/8/2022; DHS061220A1R1-S, Exp. 7/12/2022; DHS061920B1R1-S, Exp. 7/19/2022; DHS062320B1R1-S, Exp. 7/23/2022; DHS062420B1R1-S, Exp. 7/24/2022; DHS081120A1-S, Exp. 9/11/2022; DHS081220A1R1-S, Exp 9/12/2022; DHS081420B1-S, DHS081420B3-S, DHS081420B6-S, DHS081420B8-S, Exp. 9/14/2022; DHS081720A3-S, DHS081720A5-S, Exp. 9/17/2022
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sanit Technologies, LLC dba Durisan
Reason for Recall:
CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, packaged in 80-count canister (UPC 8 52379 00632 5), b) 160-count canister (UPC 8 52379 00631 8), and c) 240-count canister (UPC 8 52379 00633 2); Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243.

Product Codes/Lot Numbers:

DHS041519A1-S, DHS041519A2-S, DHS041519A3-S, DHS041519A4-S, DHS041519A5-S, DHS041519A6-S, Exp. 5/15/2021; DHS042919AR1-S, Exp. 5/29/2021; DHS043019AR1-S, Exp. 5/30/2021; DHS050319A4-S, Exp. 6/03/2021; DHS053019A1-S, DHS053019A2-S, DHS053019A4-S, DHS053019A5-S, DHS053019A6-S, Exp. 6/30/2021; DHS070219A1-S, DHS070219A2-S, DHS070219A3-S, DHS070219A4-S, DHS070219A5-S, DHS070219A6-S, DHS070219AB-S, Exp. 8/2/2021; DHS080219A1-S, Exp. 9/2/2021; DHS091819A1-S, Exp 10/18/2021; DHS032820B1-S, Exp 4/28/2022; DHS051520A1R1-S, Exp. 6/15/2022; DHS052020A1R1-S, DHS052020B1R1-S, DHS052020CR1-S, Exp. 6/20/2022; DHS052220A1R1-S, Exp. 6/22/2022; DHS052720C1R1-S, Exp 6/27/2022; DHS052920A1R1-S, DHS052920B1R1-S, DHS052920C1R1-S, Exp 6/29/2022; DHS060320C1R1-S, Exp. 7/3/2022; DHS060520C1R1-S, DHS060520F1R1-S, Exp. 7/5/2022; DHS060820E1R1-S, Exp. 7/8/2022; DHS061220A1R1-S, Exp. 7/12/2022; DHS061920B1R1-S, Exp. 7/19/2022; DHS062320B1R1-S, Exp. 7/23/2022; DHS062420B1R1-S, Exp. 7/24/2022; DHS081120A1-S, Exp. 9/11/2022; DHS081220A1R1-S, Exp 9/12/2022; DHS081420B1-S, DHS081420B3-S, DHS081420B6-S, DHS081420B8-S, Exp. 9/14/2022; DHS081720A3-S, DHS081720A5-S, Exp. 9/17/2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0659-2021

Related Recalls

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

Sanit Technologies, LLC

Class I - Dangerous

CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.

Mar 10, 2021 Other Drugs Nationwide View Details →

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

Sanit Technologies, LLC

Class I - Dangerous

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.

Mar 10, 2021 Other Drugs Nationwide View Details →