Posting date: October 19, 2020
Chiefs of Ontario Health Sector COVID-19 Update: The knowledge contained in this update (Hand Sanitizers) is a synthesis of available material to date, from a variety of sources. Hand Sanitizers are for External Use Only and Precautions should be taken in their distribution at the community level. Read full update here: https://bit.ly/3j6RlII
Click here for a full list of affected products: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73385a-eng.php
Hand Hygiene and Hand Sanitizers: The COVID-19 pandemic has created an urgent need for a range of supplies to combat this virus including hand sanitizers and disinfectants. Read more here: https://www.coo-covid19.com/post/hand-hygiene-and-hand-sanitizers
Product: Hand sanitizers that may pose health risks.
Issue: Certain hand sanitizers are being recalled because they either contain ingredients that are not permitted by Health Canada or are not properly labelled and are missing important information.
What to do: Stop using the identified product lots below. Consult your health care professional if you have used any of these products and have health concerns. Report any health product adverse events or complaints to Health Canada. See the additional information on buying health products safely in the links below
Certain lots of hand sanitizers are being recalled from the market because they:
contain ingredients that are not permitted by Health Canada; or
are not properly labelled and are missing important information
These products are listed in the table below. The table contains information about the reason for the recall including the use of unacceptable ingredients, and their associated risks.
Health Canada will update this list if there are other affected products. Canadians are encouraged to consult the list regularly for updates.
What you should do
Stop using the products identified in the table.
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 company if you would like more information about the recall
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. If soap and water are not available, use alcohol-based hand sanitizers that have been authorized for sale in Canada. Consult:
the list of Health Canada-authorized hand sanitizers; and
the list of hand sanitizers authorized or registered in other jurisdictions that may not display a Natural Product Number (NPN) or Drug Identification Number (DIN) but have been accepted for use in Canada during the COVID-19 pandemic
Report any health product adverse events or complaints to Health Canada.
The COVID-19 outbreak has created a high demand for hand sanitizers. To increase the supply, Health Canada has taken several measures, including permitting 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. They must receive a No Objection Letter from us before they can manufacture or distribute 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," "Not recommended 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"
Hand sanitizers that contain unacceptable grades of ethanol or denaturants that are not approved for sale in Canada have not been reviewed for safety or efficacy. Denaturants are added to ethanol to make it taste bad, to discourage the unintentional ingestion of hand sanitizers, especially by children.
Two unauthorized denaturants have been found in hand sanitizers sold in Canada:
Ethyl acetate: Frequent use of hand sanitizer containing ethyl acetate may cause dry skin, leading to irritation or cracking
Methanol: Frequent use of hand sanitizer containing methanol may cause dermatitis, eye irritation, upper respiratory system irritation and headaches
Certain hand sanitizers are being recalled because they either contain ingredients that are not permitted by Health Canada or are not properly labelled and are missing important information. Click here for a full list of affected products: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73385a-eng.php