Unauthorized Libigrow Found on the Québec Market

Starting date:

March 15, 2013

Posting date:

March 15, 2013

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-26185

• 
  Issue
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Issue

An unauthorized natural health product, “Libigrow” was tested by Health Canada and found to contain hidden ingredients (sildenafil and tadalafil) that may pose serious risks to the health of Canadians. “Libigrow” was being sold at two retail locations in the province of Québec: Boutique Sexie folie Inc. (Sainte-Catherine) and at Boutique Érotique 5ième avenue Inc. (Valleyfield).

This product is promoted as a male sexual stimulant and contains hidden prescription medications. Approved drugs that contain these medications can only be sold with a prescription and by a pharmacy. The purchase of such products elsewhere can put your health at serious risk.

What you should do

• Consult your healthcare practitioner with any questions or concerns regarding use of “Libigrow”.
• Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Some natural health products (NHPs) may have an Exemption Number (EN).
• Report any adverse reaction potentially related to “Libigrow” or other health products to Health Canada.
• Contact Health Canada’s toll-free line at 1-800-267-9675 with questions or complaints about “Libigrow” or other health products.

Who is affected

Canadians who have purchased or used these products, particularly people with heart problems.

Background

Sildenafil and tadalafil are prescription medications that should only be used under the supervision of a health care practitioner. Products containing sildenafil or tadalafil should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they can cause potentially life-threatening low blood pressure.

Individuals with heart problems including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardiovascular side-effects if they engage in sexual activity, including if they use sildenafil or tadalafil to help them achieve an erection. Other possible side-effects of using sildenafil or tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact Health Canada’s Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

What Health Canada is doing

Boutique Sexie folie Inc. consented to forfeit its supply of “Libigrow” to Health Canada inspectors. “Libigrow” was sold at Boutique Érotique 5ième Avenue until December 2012. Health Canada is also working with the Canada Border Services Agency to stop any further shipments of “Libigrow” from entering Canada. The product’s manufacturer, as identified on the label, is H&K Nutraceuticals, located in Los Angeles.

Images

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