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Testing confirms Bio Life hand sanitizer poses health risks; products recalled across Canada
- Starting date:
- October 18, 2020
- Posting date:
- October 28, 2020
- Type of communication:
- Advisory
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information
- Audience:
- General Public, Healthcare Professionals
- Identification number:
- RA-74137
Last updated:
Summary
- Product: Bio Life hand sanitizer by Bio Life Sciences Corp. / 10932540 Canada Inc. (Bio Life)
- Issue: Testing confirmed that Bio Life hand sanitizer contains methanol, which may cause serious health issues. It also does not contain enough ethanol to be an effective sanitizer. The company recalled all lots of this product in November 2020.
- What to do: If you have purchased this product, stop using it immediately. Consult your healthcare provider if you have used this product and have health concerns. Keep all hand sanitizers out of the reach of children. If swallowed, call a poison control centre or seek medical help immediately. Report any adverse health events or product complaints to Health Canada.
UPDATE: January 29, 2021
Health Canada testing confirmed that Bio Life hand sanitizer by Bio Life Sciences Corp. / 10932540 Canada Inc. (Bio Life) contains methanol, which may cause serious health issues, especially if ingested. Testing also showed that it does not contain enough ethanol to be an effective sanitizer. At the direction of Health Canada, Bio Life recalled all lots of Bio Life hand sanitizer in November 2020 due to suspected methanol. Given the confirmed health risk, Health Canada is reminding Canadians to stop using this product if they have it.
Bio Life recalled another hand sanitizer, Daily Shield, in October 2020 because of the presence of methanol and insufficient ethanol (see Oct. 28, 2020, advisory, below). The Bio Life and Daily Shield products were sold at retail stores across Canada.
Since the Oct. 28, 2020, advisory, Health Canada has revoked the company's COVID-19 site licence, which means that Bio Life is no longer authorized to manufacture, package, label or import hand sanitizer products in Canada. Additionally, all of Bio Life's product licences have been discontinued, which means the products can no longer be sold in Canada.
The Department continues to monitor the situation and will keep Canadians informed.
Health Canada maintains a hand sanitizer recall webpage that Canadians are encouraged to check regularly for updates on these and other recalled hand sanitizers.
History
UPDATE: Oct. 28, 2020 - Recall of Daily Shield Hand Sanitizers across Canada
Summary
- Product: All Daily Shield Hand Sanitizers
- Issue: Bio Life Sciences Corp. / 10932540 Canada Inc. is recalling all Daily Shield hand sanitizers from retail locations across Canada, due to the presence of methanol, which may cause serious health issues, effective immediately.
- What to do: If you purchased this product, stop using it immediately. Consult your healthcare provider if you have used this product and have any health or safety concerns. Keep all hand sanitizers out of the reach of children. If swallowed, call a poison control centre or seek medical help immediately. Report any adverse health event or product complaint to Health Canada.
UPDATE: Oct. 28, 2020
Bio Life Sciences Corp. (Bio Life) is recalling all Daily Shield hand sanitizers from retail locations across Canada, effective immediately.
Upon further investigation, Health Canada has determined that Daily Shield hand sanitizer labelled with NPN 80098979, Lot 6942, Expiry May 2023, is not a counterfeit product as initially communicated on October 18, 2020, based on new information provided to Health Canada by Bio Life. The product may have been sold at retailers other than Dollarama, and Health Canada is working to verify that it is no longer being sold by any distributors or retailers.
Testing of Daily Shield hand sanitizer confirmed the presence of methanol, which is not authorized for use in hand sanitizers and can cause serious health issues. Frequent use of hand sanitizer containing methanol may cause dermatitis, eye irritation, upper respiratory system irritation and headaches. If ingested, methanol can cause severe, even deadly adverse reactions. As a result, Health Canada directed Bio Life to stop selling and recall all Daily Shield hand sanitizers immediately.
In addition, testing also confirmed that the ethanol content of the Daily Shield hand sanitizer is less than the recommended amount, and this product is therefore not likely to provide effective hand sanitizing functions, such as killing germs and bacteria.
Health Canada also identified that Bio Life had a number Good Manufacturing Practices (GMP) violations, including poor record keeping, lack of control of inventory, and lack of finished product testing.
As a result, Health Canada directed the company to stop all licensable activities. All product licences held by the firm have been suspended and an intent to revoke the COVID-19 site licence has been issued. Health Canada is continuing to follow up on Bio Life's other products to determine if other action is needed.
| NPN | Product Name | Dosage Form |
|---|---|---|
| 80098979 | Daily Shield | Gel |
| 80099718 | Daily Shield | Liquid |
| 80099984 | Daily Shield | Wipe, medicated |
| 80101022 | Bio Life | Wipe, medicated |
| 80101522 | Bio Life | Gel |
| 80101733 | Bio Life | Liquid |
Health Canada encourages consumers to always read and follow the directions on product labels. Hand sanitizers are for external use only and should never be ingested, as even small amounts can be dangerous or fatal.
Health Canada will continue to monitor the situation and update its hand sanitizer recall webpage should any additional recalls be necessary.
Original Public Advisory: October 18, 2020 - Counterfeit Daily Shield Hand Sanitizer
Summary
Product: Daily Shield Hand Sanitizer (NPN 80098979); Lot 6942; Expiry May 2023.
Issue: A counterfeit version of Daily Shield hand sanitizer (labelled with NPN 80098979, Lot 6942, Expiry May 2023) has been found for sale at a Dollarama location in Thunder Bay and may have been sold at Dollarama stores across Canada. Health Canada is confirming the complete list of locations where the product was sold.
What to do: If you purchased this product, stop using it immediately. Consult your healthcare provider if you have used this product and have any health or safety concerns. Keep all hand sanitizers out of the reach of children. If swallowed, call a poison control centre or seek medical help immediately. Report any adverse health event or product complaint to Health Canada.
Issue
Health Canada is informing Canadians that a counterfeit version of the authorized Daily Shield hand sanitizer has been found for sale at a Dollarama store in Thunder Bay. The counterfeit version is labelled with NPN 80098979, Lot 6942; Expiry May 2023 and is sold in a 250 mL format.
Health Canada has been advised by the authorized licence holder, Bio Life Sciences Corp. / 10932540 Canada Inc., that the product bearing the lot number Lot: 6942, Exp. May/2023 is counterfeit.
As the counterfeit version of Daily Shield hand sanitizer is unauthorized and made with an unknown formulation, it may not be effective at killing bacteria and viruses, and may pose serious risks to health. This counterfeit product is suspected to contain methanol, which is not authorized for use in hand sanitizers and could cause severe adverse reactions or death when ingested.
Counterfeit products are fraudulent versions of authentic products and may be harmful if used or consumed. Counterfeit products may contain ingredients not listed on the label, dangerous additives or other contaminants. In addition, they may not contain the active ingredients that Canadians would expect them to contain.
Dollarama has agreed to stop the sale of Daily Shield hand sanitizer in Dollarama stores across Canada, while Health Canada continues to investigate the issue.
Health Canada is committed to stopping the production and import of unauthorized or counterfeit drugs in Canada and will not hesitate to take additional actions as necessary to stop this illegal activity. For more information regarding Health Canada's approach to counterfeit health products please consult Health Canada's Policy on Counterfeit Health Products.
Hand sanitizers should be stored away from, and out of sight of, children under six years of age. They should always be used with adult supervision. As with all health products, always read and follow the directions on the product label. Never eat or drink hand sanitizers as ingesting even small amounts can be dangerous or fatal.
What consumers should do
- If you have this product, stop using it.
- Consult your healthcare practitioner if you have used this product and have concerns regarding your health.
- Keep all hand sanitizers out of the reach of children.
- If this product is swallowed, call a poison control centre or seek medical help immediately.
- Report any adverse health event or product complaint 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
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