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Stiff One Hard 169 product recalled from the Canadian market: may pose serious health risks to Canadians

Starting date:
November 30, 2011
Posting date:
November 30, 2011
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-110004713

Issue

An unauthorized health product, "Stiff One Hard 169" is being voluntarily recalled from the Canadian market after Health Canada's testing identified an undeclared prescription medication in the product (thiodimethylsildenafil, an undeclared substance similar to the prescription medication sildenafil).

"Stiff One Hard 169" is being promoted as a dietary supplement and may pose serious risks to the health of Canadians. "Stiff One Hard 169" was being sold at retail locations in British Columbia, Alberta, Ontario, Québec and via the internet at the following web sites: http://sexy-living.com and http://sexyliving.com. It is important to note that the product may be sold elsewhere.

Who is affected

Canadians who have purchased "Stiff One Hard 169", particularly individuals with heart problems, those at risk of stroke or those taking any nitrate drug (e.g. nitroglycerine) are affected.

What you should do

  • Consult your healthcare practitioner if you have used this product or are concerned about your health.
  • Report any adverse reaction potentially related to this product to Health Canada.
  • Submit complaints regarding the sale of these or any other unapproved health products, or concerns related to the safety, efficacy or quality of health products, to Health Canada's Inspectorate, toll-free, at 1-800-267-9675.
  • Contact CANA International Distributing Inc (604-983-6969) about disposal and/or returning this product to the point of purchase.
  • 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), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.

Background

Sildenafil should only be used under the supervision of a health care practitioner. Products containing sildenafil should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it 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 cardio-vascular side effects if they engage in sexual activity, including if they use sildenafil to help them achieve an erection. Other possible side-effects of using sildenafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Canadians who have taken unauthorized prescription products without the supervision of a healthcare practitioner or without a prescription may face additional risks. You may be misdiagnosed, the treatment might not be appropriate to treat your illness and you may miss the opportunity to obtain appropriate medical treatment. You may also put yourself at risk for drug interactions, or harmful side effects.

Report health or safety concerns

How to report problems with consumer products:

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:

  • Facsimile: 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

Health Canada is monitoring the voluntary recall of "Stiff One Hard 169", and working with Canada Border Services Agency to help stop future shipments of this product from entering Canada.

Should Health Canada become aware that this product remains available for sale in these or other locations in Canada, the Department will take appropriate action.

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