Health Canada seized two unauthorized ZO Medical skin-whitening creams from Toronto Dermatology Centre in North York, Ontario, because they may pose serious health risks

Starting date:
January 3, 2020
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Identification number:
RA-72037

Last updated:

Summary

  • Product: ZO Medical Melamin-C Skin Bleaching & Correcting Crème with 20% vitamin C, and ZO Medical Melamix Skin Lightener & Blending Crème.
  • Issue: Products are unauthorized and labelled to contain a prescription drug, which may pose serious health risks.
  • What to do: Stop using these products. Consult your healthcare professional if you have used any of these products and have health concerns.

Issue

Health Canada is advising Canadians that it seized two unauthorized ZO Medical skin-whitening creams from Toronto Dermatology Centre (4256 Bathurst St. Suite 400) in North York, Ontario, because they may pose serious health risks, such as blisters, scarring, skin discolouration and possibly cancer.  

The products are labelled to contain a 4% hydroquinone concentration. As of June 30, 2019, products for topical use exceeding a 2% hydroquinone concentration require a prescription from a healthcare practitioner in order to be sold in Canada. Prescription drugs should be used only under the advice and supervision of a healthcare professional because they are used to treat specific conditions and may cause serious side effects.

Health Canada withdrew its authorization for all topical products exceeding a 2% hydroquinone concentration that were previously available for sale without a prescription, and companies voluntarily recalled these products from the Canadian market. The Toronto Dermatology Centre was found to be selling the two products that were subsequently seized by Health Canada, despite the fact that it is illegal to sell unauthorized health products and that the products had been recalled.

Affected products

Photo Product Prescription drug listed on product label
ZO Medical Melamin-C Skin Bleaching & Correcting Crème with 20% vitamin C ZO Medical Melamin-C Skin Bleaching & Correcting Crème with 20% vitamin C Hydroquinone 4%
ZO Medical Melamix Skin Lightener & Blending Crème ZO Medical Melamix Skin Lightener & Blending Crème Hydroquinone 4%

 

What you should 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-related adverse reactions or complaints to Health Canada.

Who is affected

Consumers who have bought or are using the affected products.

Background

Hydroquinone for topical use at concentrations above 2% is a prescription drug used to lighten areas of darkened skin caused by different conditions (e.g., sun exposure, skin damage, pregnancy, medications or age). It should not be used by people who are allergic to hydroquinone or who are taking medicines that make their skin more sensitive to light. Hydroquinone is not recommended for pregnant or breastfeeding women, or children. It should be used with caution in those who have previously had cancer. Side effects include skin reactions such as redness, dryness, cracked skin, burning, stinging, peeling, itching, increased sensitivity to sunlight, sunburn, blisters and scarring. It may cause skin discolouration (i.e., blue or black discolouration or white patches or spots) that, in some cases, can be disfiguring. In laboratory animals, it has been associated with cancer after long-term exposure.

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 seized the two products and directed the clinic to stop selling unauthorized health products. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians as necessary.

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