Hand sanitizers labelled as "Anti-Microbe" and/or with DIN 02248351 recalled because they may pose health risks, particularly to children

Starting date:
January 22, 2021
Type of communication:
Advisory
Subcategory:
Drugs, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-74849

Last updated:

Summary

  • Product: Various 0.3% benzalkonium chloride hand sanitizers labelled as “Anti-Microbe” and/or with Drug Identification Number (DIN) 02248351.
  • Issue: They are being recalled because they contain a higher concentration of benzalkonium chloride than permitted for personal or domestic (i.e., home) use and may pose health risks, particularly to children up to 12 years of age.
  • What to do: Stop using these products. Consult your health care professional if you have health concerns after using these products.

Issue

Atoms F.D. Inc. is recalling various 0.3% benzalkonium chloride hand sanitizers labelled as “Anti-Microbe” and/or with the Drug Identification Number (DIN) 02248351 because they contain a higher concentration of benzalkonium chloride than permitted for personal or domestic (i.e., home) use and may pose health risks, particularly to children up to 12 years of age.

Benzalkonium chloride cannot exceed a 0.15% concentration in hand sanitizers intended for personal or domestic use. Products containing 0.3% benzalkonium chloride should be labelled for adult use in an industrial setting only (e.g., health care and food processing facilities). The affected products are not appropriately labelled with this information. Health Canada is aware that some products were distributed to various schools in Quebec, for use by children. The products were also sold online and in stores to the general public, mainly in Ontario and Quebec.

Benzalkonium chloride is primarily used as a preservative and antimicrobial agent. In Canada, it is a known active ingredient in hard surface disinfectants and hand sanitizers. The frequent, daily use of hand sanitizers containing 0.3% benzalkonium chloride may cause red, itchy, dry or scaly skin in susceptible individuals. In some cases, peeling, swelling or blistering can occur. In rare cases, an allergic reaction can happen and can be serious. Signs of an allergic reaction include rash and hives; swelling of the mouth, face, lips, tongue or throat; chest or throat tightness; and wheezing or trouble breathing. Young children, adolescents, and people with skin conditions like eczema are particularly at risk of side effects involving frequent use.

The affected products are sold under various product and company names (see list below) in various sizes and packaging formats.

Health Canada has directed the license holder, Atoms F.D. Inc., to recall the affected products from the market, and to correct the labelling issue by ensuring that products are clearly labelled “For industrial use only” and “Keep out of reach of children,” as per their market authorization. While the company confirmed that it had initiated the recall in December 2020, Health Canada’s monitoring activities found that the recall was not conducted effectively and that impacted products may still be on the market. Health Canada will continue to monitor the effectiveness of the recall. If an additional safety concern is identified, Health Canada will take action and inform Canadians.

Affected products

In addition to Atoms F.D. Inc. (the license holder and recalling company), Health Canada is aware that companies are selling the affected product under their own label (i.e., private labels). This list of affected products may not be complete: 

Product Company
Anti-Microbe Atoms F.D. Inc. (license holder and recalling company)
32 Anti-Microbe Groupe BOD
Essence 360 Anti-Microbe Essence360 International
Nutra One Anti-Microbe Nutra One Inc.
Paoch Anti-Microbe Entreprise Paoch Inc.
Produits Bio-Expert Anti-Microbe Produits Bio-experts Inc.
Trilux Anti-Microbe Trilux
Yunisan Handzo Arclay Natural Technologies Inc.

What you should do

  • Stop using hand sanitizers labelled as "Anti-Microbe" and/or with the DIN 02248351,
    • Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or
    • Return the product to your local pharmacy for proper disposal.
  • Contact the recalling company, Atoms F.D. Inc., by calling 1-514-745-2597, or by email at info@atomesbio.com if you would like more information about the recall.
  • Consult your health care professional if you have health concerns after using these products.
  • Report any health product adverse events or complaints to Health Canada.

Related links:

Media Enquiries:

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public Enquiries:

(613) 957-2991
1-866 225-0709
hcinfo.infosc@canada.ca