Unauthorized skin lightening products seized from Blue Sky Supermarket: products may pose serious health risks

Starting date:
March 10, 2020
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-72543

Last updated:

Summary

  • Product: Unauthorized skin lightening products from Blue Sky Supermarket in Pickering, ON.
  • Issue: Products are labelled to contain prescription drugs that may pose serious health risks.
  • What to do: Stop using these products. Consult your health care professional if you have used any of these products and have health concerns.

Issue

Health Canada has seized unauthorized skin lightening products from Blue Sky Supermarket in Pickering, ON (1805 Pickering Pkwy). These products, which are not authorized for sale, are labelled to contain the prescription drug tretinoin and may pose serious health risks.

Topical tretinoin is used to treat acne and has been associated with birth defects. Other side effects include pain, irritation, itchiness, redness, or swelling at the site of application. It may damage skin, change skin colour, and increase sensitivity to sunlight or tanning beds, causing sunburns. The seized products also contain hydroquinone at concentrations of 2%. The use of tretinoin and hydroquinone in combination can make the side effects of tretinoin worse.

Health Canada is encouraging Canadians to read the labels of products that claim to lighten, whiten, fade or bleach skin. Look for an eight-digit Natural Product Number (NPN) or Drug Identification Number (DIN) on the label, which indicates the product has been assessed by Health Canada for safety, efficacy and quality, and has been authorized for sale.

Health products that have not been authorized for sale by Health Canada may contain high-risk ingredients, such as prescription drugs, that may or may not be listed on the product label. 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.

It is illegal to sell unauthorized health products in Canada. Health Canada has seized and warned Canadians about several unauthorized skin lightening health products whose labels show they contain prescription drugs (e.g., betamethasone dipropionate, clobetasol propionate, or hydroquinone at concentrations greater than 2%). These products may pose health risks, such as blisters, scarring, skin weakening or deterioration, bone loss, decreased ability to fight infection, and, in the case of hydroquinone at concentrations greater than 2%, possibly cancer. The Department strongly encourages Canadians to not use these products and to report to Health Canada if they see the products for sale, so that the Department can take appropriate action.

Unauthorized skin lightening products may also contain unacceptable levels of mercury, a heavy metal. Mercury poisoning can cause serious harm, particularly to children, pregnant women and women who are breastfeeding. The Department has implemented measures to reduce the amount of heavy metals to which Canadians are exposed, including establishing strict limits for health products and cosmetics.

Side effects

Affected products
Photo Product Risk
Maxi-Peel Exfoliant Solution 1 Maxi-Peel Exfoliant Solution 1
Skin lightening
labelled to contain tretinoin and 2% hydroquinone
Maxi-Peel Exfoliant Solution 2 Maxi-Peel Exfoliant Solution 2
Skin lightening
labelled to contain tretinoin and 2% hydroquinone
Maxi-Peel Exfoliant Solution 3 Maxi-Peel Exfoliant Solution 3
Skin lightening
labelled to contain tretinoin and 2% hydroquinone
  • Stop using these products. Consult your health care professional if you have used these products and have health concerns.
  • Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
  • Report any health product adverse events or complaints to Health Canada.

Health Canada seized the products from Blue Sky Supermarket in Pickering, ON. Should additional products, retailers or distributors be identified, Health Canada will take appropriate action and inform Canadians as necessary.

Who is affected

Consumers who have bought or who are using the affected products.

Background

Topical tretinoin is a prescription drug used to treat acne. Topical tretinoin should not be used during pregnancy, as it has been associated with birth defects. This product should not be used by nursing women, children under 12 years old, individuals with inflamed or irritated skin, those with a previous skin cancer or undiagnosed skin lesions, and those taking medicines that make their skin more sensitive to light. Tretinoin may cause pain, irritation, itchiness, redness, or swelling at the site of application. It may damage skin, change skin colour, and increase sensitivity to sunlight or tanning beds, causing sunburns. Using tretinoin in combination with hydroquinone may increase some of the side effects of tretinoin. Individuals who are allergic to either tretinoin or hydroquinone should not use this combination product.


Images

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