Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Starting date:

October 18, 2018

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Unauthorized products

Audience:

General Public

Identification number:

RA-68036

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Issue

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario. 

Surfaz-SN Triple Action Cream has not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

Products affected

Surfaz-SN Triple Action Cream

What you should do

• Do not use this product. Consult with your health care professional if you have used it 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 this product, particularly pregnant or nursing women.

Background

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 seized the product from the retail location. Should additional retailers or distributors be identified, Health Canada will take appropriate action and inform Canadians as necessary.

Images

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