Advisory - Removal of Potentially Dangerous Products from Retail Locations in B.C. and Saskatchewan

OTTAWA, May 23, 2012 /CNW/ -

The issue:

Unauthorized health products, "X-Rock", "Kaboom" and "One For Her" have been removed from sale from various retail outlets in British Columbia and Saskatchewan. Health Canada's testing of these products identified undeclared prescription drugs sildenafil, and tadalafil and an undeclared substance, hydroxythiohomosildenafil, which is similar to sildenafil. These products may pose serious cardiovascular risks to the health of Canadians.

The products were distributed by "It Erotics" to: an additional Happy Paradise Adult Store in Burnaby, BC; Ultimate Amore in Burnaby, B.C.; Source Adult in Coquitlam, B.C.; O'Behave Home Parties Ltd. in Surrey, BC and Source Adult in Saskatoon, Saskatchewan. It is important to note that these products may have been sold in additional retail locations.

Who is affected:

Canadians who have purchased "X-Rock", "Kaboom" and/or "One For Her" particularly individuals with heart problems, those at risk of stroke or those taking any nitrate drug (e.g. nitroglycerine).

What consumers should do:

• Speak to your healthcare practitioner with any questions or concerns regarding these products.
  
• Contact It Erotics at 604-540-4238 concerning the recall of this product.
  
• Report any adverse reaction potentially related to these products to Health Canada (see below).
  
• 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 by "It Erotics" and has requested that they stop selling unauthorized health products.

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 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 or tadalafil to help them achieve an erection. Other possible side-effects of using sildenafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Hydroxythiohomosildenafil is an unauthorized substance similar to sildenafil.

As of today, Health Canada has not received any adverse reactions reports associated with the use of these products.

Products affected:
http://files.newswire.ca/1043/health.pdf

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 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: [phone]
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

Related Health Canada Web content:

• Advisory (January 23, 2012): "Unauthorized Products Removed from Sale at Additional Stores in Burnaby, B.C.
• 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: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

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PDF available at: http://stream1.newswire.ca/media/2012/05/23/20120523_C9996_DOC_EN_14084.pdf

Media Enquiries: 
Health Canada
[phone]

Public Enquiries:
[phone]
1-866 225-0709