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Unauthorized health products removed from sale at Burnaby and Richmond stores: may pose serious health risks to Canadians

Starting date:
June 14, 2011
Posting date:
June 14, 2011
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Unauthorized products
Audience:
General Public
Identification number:
RA-110005118

Revised June 16, 2011

Issue

In response to a consumer complaint, a number of unauthorized health products including sexual enhancement products, that may pose serious risks to the health of Canadians, were removed from sale at Male and Female Harmony retail stores in Richmond and Burnaby, B.C., along with the Happy Paradise Adult Store in Burnaby.

Health Canada's testing of these products has identified the presence of undeclared prescription medication in these products, which may pose serious health risks.

Who is affected

Canadians who have purchased any of the affected products.

What you should do

  • Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
     
  • 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.
     
  • Report any adverse reaction potentially related to these products to Health Canada (see below).

What Health Canada is doing

Health Canada is currently reviewing additional products found at these stores and will continue to update the list of affected products if new products are identified. Canadians are advised to monitor this list for any updates. Should Health Canada become aware that these products continue to be sold,   the Department will take appropriate action.

Background

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.

Health Canada would also like to remind Canadians to read the labelling of the products they buy to verify that the products 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 Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) 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.

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:

Product List

In response to a consumer complaint, a number of unauthorized sexual enhancement health products that may pose serious risks to the health of Canadians were removed from sale at retail stores and tested by Health Canada. Our testing has identified the presence of undeclared prescription medication(s) in these products (see the list below):

Sildenafil

Sildenafil is a prescription medication that should only be used under the supervision of a health care practitioner. Products authorized for sale containing sildenafil should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine), as sidenafil in combination with a nitrate drug, can cause potentially life-threatening low blood pressure. As with all treatments for erectile dysfunction, there is a potential cardiac risk associated with sexual activity in patients with pre-existing heart problems such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Tadalafil

Tadalafil should only be used under the supervision of a health care practitioner. Products containing 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 tadalafil to help them achieve an erection. Other possible side-effects of using tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Phenolphthalein

Phenolphthalein, which was previously used as a laxative, is no longer authorized for sale in Canada because it may cause cancer. Additional side-effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

Health Canada is aware that there may be other products on the market with the same name but not necessarily the same ingredients. The information in this alert refers only to the product labelled as below.

List of Products
Product Name Ingredient Retailer City Date Added
Black Gold Sildenafil Male and Female Harmony Store 4540 No.3 Road,
Richmond, BC
June 14, 2011
4619 Kingsway,
Burnaby, BC
Magna-RX Sildenafil Happy Paradise Adult Store 4560 Kingsway,
Burnaby, BC
June 14, 2011
V100 Sildenafil Male and Female Harmony Store 4540 No.3 Road,
Richmond, BC
June 14, 2011
4619 Kingsway,
Burnaby, BC
VigRX for Men Sildenafil Male and Female Harmony Store 4540 No.3 Road,
Richmond, BC
June 14, 2011
4619 Kingsway,
Burnaby, BC

Media enquiries

Health Canada
613-957-2983

Public enquiries

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

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