Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Starting date:
August 1, 2018
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Unauthorized products, Important Safety Information
Audience:
General Public
Identification number:
RA-67334

Update – August 17, 2018
This advisory has been updated to reflect that Health Canada has seized two unauthorized skin products labelled to contain prescription drugs. Neoprosone Gel Forte was seized from Elikya Canada and Diproson Cream was seized from an additional distributor (Abeit Distributions Inc.)

Original Advisory – August 1, 2018

Issue

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Prescription drugs can only be dispensed by a healthcare professional to a patient with a valid prescription. The products listed below have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

Affected product
Image Product Name Labelled Ingredient Company
Betasol Cream Betasol Cream clobetasol propionate 0.05% Ayotai Canada
Betasol Lotion Betasol Lotion clobetasol propionate 0.05% Ayotai Canada
Diproson Cream Diproson Cream betamethasone dipropionate 0.05% Ayotai Canada

Abiet Distributions Inc. (added August 17, 2018)
Haloderm Haloderm clobetasol propionate 0.05% Ayotai Canada
L'abdijanaise Cream L’abdijanaise Cream clobetasol propionate 0.05% Ayotai Canada
Lemonvate Cream Lemonvate Cream clobetasol propionate 0.05% Ayotai Canada
Natural Papaya Cream Natural Papaya Cream clobetasol propionate 0.05% Ayotai Canada
Nature Secrète Cream Nature Secrète Cream clobetasol propionate 0.05% Ayotai Canada
Neoprosone Gel Forte Neoprosone Gel Forte betamethasone dipropionate 0.05%

Neomycin sulphate 0.1%
Elikya Canada (added August 17, 2018)

What you should do

  • Do not use these products. Consult with your health care professional if you have used any of 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 adverse events to health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
  • Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Who is affected

  • Consumers who have bought or used these products, particularly pregnant or nursing women.

Background

Clobetasol propionate is a highly potent topical (applied to the skin) corticosteroid prescription drug used to treat inflammatory skin conditions. It should be used only under the supervision of a health care professional. Side effects include skin irritation, weakening or deterioration. Topical corticosteroids can be absorbed in sufficient amounts to produce adverse effects, including symptoms of adrenal suppression (low blood pressure, low blood sugar, weight loss, muscle pain, gastrointestinal problems, and severe fatigue) or Cushing’s syndrome (high blood pressure, high blood sugar, weight gain, muscle weakness, bone loss, and severe fatigue) depending on how much has been absorbed. Clobetasol should not be used by pregnant or nursing women.

Betamethasone dipropionate is a highly potent corticosteroid prescription drug that can be used topically (applied to the skin) to treat inflammatory skin conditions. It should be used only under the supervision of a health care professional. Side effects from topical use include skin irritation and, with prolonged use, skin weakening or deterioration. Topical corticosteroids can be absorbed in sufficient amounts to produce adverse effects, including symptoms of adrenal suppression (low blood pressure, low blood sugar, weight loss, muscle pain, gastrointestinal problems, and severe fatigue) or Cushing’s syndrome (high blood pressure, high blood sugar, weight gain, muscle weakness, bone loss, and severe fatigue) depending on how much has been absorbed. Betamethasone dipropionate should not be used by pregnant or nursing women.

Neomycin sulphate is an antibiotic prescription drug and should be used only under the supervision of a health care professional. Side effects include allergic reactions that range from mild skin reactions (itching, rash and hives) to severe, life-threatening allergic reactions (anaphylaxis). Side effects—such as damage to nerve tissue or the central nervous system, inner ear, and organs responsible for hearing and balance, and reduced kidney function—have occurred in patients taking neomycin orally (by mouth) or when applied on the skin to open wounds or damaged skin. As well, when not used as directed, neomycin sulphate could increase the risk of infections resistant to neomycin or other antibiotics. Neomycin sulphate should not be used by pregnant or breastfeeding women unless directed by a healthcare professional.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada has seized the products from the company warehouse and has requested the company recall the products already distributed. Should additional retailers or distributors be identified, Health Canada will take appropriate action and inform Canadians as necessary.

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