Recall of certain hand sanitizers that contain technical-grade ethanol

Starting date:
June 24, 2020
Posting date:
August 7, 2020
Type of communication:
Advisory
Subcategory:
Drugs, Natural health products
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-73421

Last updated:

Summary

  • Product: Certain hand sanitizers made with 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.
  • What to do: Stop using these products. Consult your healthcare 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

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.

Affected products

Certain hand sanitizers made with technical-grade ethanol

Product description

Please note that the products in the following table are listed alphabetically, rather than by the date they were added.

Affected products
Product Reason for recall Recalling Company NPN or DIN Lot number(s) Date Added
204 Hand Sanitizer Not authorized for sale in Canada; product not authorized to contain technical-grade ethanol; some lots contain technical-grade ethanol and are missing risk statements 204 Spirits Inc. None All August 7, 2020
Agape Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Formula A Inc. 80099669 (does not appear on the label)
  • 080620
July 17, 2020
Alco-Klean / Magiechem Inc. - Assainisseur À Base D'Éthanol 80%V/V Missing risk statements; product not authorized to contain technical-grade ethanol Magiechem Inc. 80099007
  • 16679-200421
July 17, 2020
Ascencia Désinfectant pour les mains Incorrect NPN; product not authorized to contain technical-grade ethanol; missing risk statements Arclay Natural Technologies 80098625 appears on the label, which is the wrong NPN. 80100505 is the correct NPN.
  • EN142
July 6, 2020
Avery Essentials Hand Sanitizer Missing risk statements; product not authorized to contain technical-grade ethanol Universal Consumer Brands 80099591
  • 20E31A
June 24, 2020
80099412
  • 20C30A
  • 20D19A
  • 20E08A
  • 20E01A
June 24, 2020
BioOrigin Pure Hands Antibacterial Hand Gel Missing risk statements; product not authorized to contain technical-grade ethanol Mineral Origin Inc. 80098887
  • 12020
  • 12720-2
  • 14020
  • 14320
July 30, 2020
BioOrigin Pure Hands Purifying Hand Cleansing Gel Missing risk statements; product not authorized to contain technical-grade ethanol Mineral Origin Inc. None
  • 09920
  • 10020
  • 10520
  • 10620
  • 11120
  • 11220
  • 12020
  • 12720
  • 13320
  • 14020
  • 14620
July 30, 2020
Med Clean Hand Sanitizer Incorrect NPN; product not authorized to contain technical-grade ethanol; missing risk statements Brands International Corporation 80021511
  • 20100001
June 24, 2020
Opti-Max Opti-Pure Missing risk statements; product not authorized to contain technical-grade ethanol Les Produits Optimax Inc. 80099476
  • 20200515
July 30, 2020
Protectenol Hand Sanitizer Missing risk statements Applied Lubrication Technology Inc. 80098373
  • 20-0110
  • 20-0111
  • 20-0112
  • 20-0113
  • 20-0114
  • 20-0115
  • 20-0116
  • 20-0117
July 6, 2020
  • 20-075 to 20-082
  • 20-084 to 20-100
  • 20-103 to 20-144
  • 20-148 to 20-209
  • 20-211 to 20-295
  • 20-298 to 20-306
  • 20-310 to 20-312
  • 20-314 to 20-330
  • 20-338 to 20-363
  • 20-397
  • 20-405
  • 20-419
  • 20-421
  • 20-422
  • 20-426
  • 20-427
June 24, 2020
Sanify Hand Sanitizer Product not authorized to contain technical-grade ethanol; missing risk statements Lusty Libation, Inc. 80099248
  • LotSan005
  • LotSan006
  • LotSan007
  • LotSan008
July 6, 2020
Visibly Clean Hand Sanitizer Not authorized for sale in Canada Brands International Corporation None All June 24, 2020

 


Sanify Hand Sanitizer (2020-06-30)

2020-06-30 | Health products, COVID-19

Recall

Protectenol (2020-06-18)

2020-06-18 | Health products, COVID-19

Recall

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

  • Health Canada has directed companies to stop the sale of these products and is monitoring the effectiveness of the recalls.
  • If Health Canada identifies additional products or manufacturers using ethanol that does not meet Health Canada requirements, the Department will take appropriate action and inform Canadians, including updating this list.
  • Health Canada has also issued a recall of certain hand sanitizers containing industrial-grade ethanol.