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Public advisory

Removal of potentially dangerous products from retail locations in British Columbia and Saskatchewan

Starting date:: May 23, 2012
Posting date:: May 23, 2012
Type of communication:: Advisory
Subcategory:: Natural health products
Source of recall:: Health Canada
Issue:: Product Safety, Undeclared Substance
Audience:: General Public
Identification number:: RA-110005676

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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 you 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 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 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

X-Rock (Sildenafil and hydroxythiohomosildenafil)
Kaboom (Sildenafil, Tadalafil and tadalafil like substances)
One For Her (Tadalafil)

How to report an adverse reaction

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