Health Canada

Health Canada

November 30, 2011 15:23 ET

"Stiff One Hard 169" Recalled From the Canadian Market: May Pose Serious Health Risks to Canadians

OTTAWA, ONTARIO--(Marketwire - Nov. 30, 2011) - The 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: and 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.

A photo of the product is available at the following address:

What consumers 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.

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.


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.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products:

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

Related Health Canada Web content:

- Advisory (July 6, 2011): 14 Additional Unauthorized Health Products Tested: May Pose Serious Health Risks (

- Advisory (July 4, 2011): "Man Up Now" Removed From Sale at Delta and Surrey Stores: May Pose Serious Health Risks to Canadians (

- Advisory (June 14, 2011): Unauthorized Health Products Removed From Sale at Burnaby and Richmond Stores: May Pose Serious Health Risks to Canadians (

- Advisory (July 13, 2010): Unapproved Health Product "UP Ultimate Performance For Men" May Pose Serious Health Risks (

- Advisory (March 8, 2010): Unapproved Health Product, "POWER-MAX" May Pose Serious Health Risks (

- Advisory (January 8, 2010) - Canadians Advised Not to use "Stiff Nights" or Any Unauthorized Product Promoted for Erectile Dysfunction (

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools:

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