Recall of certain hand sanitizers that may pose health risks (Part 1 - June 17, 2020 to March 24, 2021)

Starting date:

June 17, 2020

Posting date:

March 24, 2021

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-73385

Last updated: 2021-05-20

Summary

• Product: Hand sanitizers that may pose health risks.
• Issue: Certain hand sanitizers are being recalled because they do not meet Health Canada’s requirements.
• 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.

• Issue
• What you should do
• Background
• Affected products
• Related AWRs
• Media enquiries
• Public enquiries
• What Health Canada is doing

Issue

Certain lots of hand sanitizers are being recalled from the market because they do not meet Health Canada requirements. Reasons for recall include:

• containing (or possibly containing) ingredients that are not permitted by Health Canada;
• improper labelling;
• missing risk statements;
• being unauthorized for sale in Canada;
• being sold without proper product testing;
• being counterfeit; or
• having defective or faulty packaging.

Recalled hand sanitizers are listed in the table below. The table lists the reason for recall and includes information regarding the lot numbers of affected products.

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 these resources for more information:

• 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.

Background

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 if the ethanol impurities exceed a certain level:

• 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

An unauthorized medicinal ingredient has been found in hand sanitizers sold in Canada:

• 1-Propanol: Frequent use of hand sanitizer containing 1-propanol may cause eye, nose and throat irritation, as well as dry cracking skin, drowsiness and headache

All health products, including hand sanitizers, must be tested before they can be sold in Canada. Testing is done to ensure the product meets Health Canada’s required safety, quality and efficacy standards.

Counterfeit products may contain ingredients not listed on the label, dangerous additives or other contaminants. In addition, they may not contain the active ingredients Canadians would expect them to contain. Since counterfeit products are unauthorized and made with an unknown formulation, they may not be effective at killing bacteria and viruses, and may pose serious risks to health.

Affected products

Related AWRs

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

What Health Canada is doing

We have directed companies to stop selling these products.

We are monitoring the situation. If we identify other products that do not meet Health Canada requirements, we will take appropriate action and inform Canadians by updating this list.