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Health Canada - Recall of certain hand sanitizers that contain technical-grade ethanol

Health Canada - Recall of certain hand sanitizers that contain technical-grade ethanol

Issue

Health Canada is advising Canadians that certain hand sanitizers containing technical-grade ethanol are being recalled from the market because they are not compliant with federal regulations and may pose a risk to health.

Given supply shortages of pharmaceutical- and food-grade ethanol, on April 15, 2020, Health Canada permitted the temporary use of technical-grade ethanol in alcohol-based hand sanitizers.

Manufacturers wishing to use technical-grade ethanol must choose from a list of Health Canada-authorized suppliers and receive a No Objection Letter from Health Canada before manufacturing or distributing the product. Technical-grade ethanol contains more impurities than pharmaceutical- and food-grade ethanol. Therefore, manufacturers must include the following risk statements on their product labels:

  • Under Medicinal Ingredients: “Ethanol XX% (technical-grade)”
  • Under Directions: “Adults only”
  • Under Warnings: “Do not use on broken or damaged skin,” “Do not use if you are pregnant or breastfeeding” and “Do not inhale”
  • Include a statement for consumers: “Report any incident to Health Canada
  • Under Questions: “Call 1-866-234-2345 to report any adverse reaction”

Health Canada is advising Canadians to stop using the products on the list below. The Department will update this list if it becomes aware of other affected products, so that Canadians can easily identify ones they may have purchased and take appropriate action. Canadians are encouraged to consult the list regularly for updates. Health Canada also maintains a list of hand sanitizers that contain ethanol or denaturants that are not acceptable for use in hand sanitizers and are being recalled from the market because they may pose a risk to health.

What you should do

  • Stop using the products listed below or on the list of hand sanitizers that contain ethanol or denaturants that are not acceptable for use in hand sanitizers. Please follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste. You may also return the products to your local pharmacy for proper disposal.
  • Consult your health care professional if you have used these products and have health concerns.
  • To help limit the spread of COVID-19, wash your hands often with soap and water for at least 20 seconds. Use alcohol-based hand sanitizers if soap and water are not available.
  • Use hand sanitizers that have been authorized for sale in Canada. These products can be found on the list of hand sanitizers that meet Health Canada's requirements or have been allowed to be imported under an interim measure.
  • Report any health product adverse events or complaints to Health Canada.

For more information about the affected product, click here.

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