Foreign Product Alert: Enhanced Vegetal Vigra capsules, Extreme Diamond 3000, Gold Viagra capsules, Gold Viagra tablets (packaged as "Kangaroo Sexually Invigorating Essence"), Majestic Lovezone tablets, Niu Mo Wang 'Bull Monster' tablets, North West Wolf capsules, Strong Horses capsules, Strong-SX capsules, USA Gold Ant capsules, Black Mamba Hyperrush, Botanical Slimming (Red), Green Algae Combination by Crane Beauty, Natural Max Slimming, OMG Slim capsules, Skinny 22", Ultra ZX, Ultimate Boost, Xcel, Xcel Advanced

Starting date:

July 2, 2015

Posting date:

July 2, 2015

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Undeclared Substance, Important Safety Information

Audience:

General Public

Identification number:

RA-53996

• Issue
• What you should do
• Report health or safety concerns
• Images

Issue

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

The products are not authorized for sale in Canada and have not been found in the Canadian marketplace but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Unauthorized foreign health products

Product Name(s)	Hazard(s) Identified	Source of Alert	Other product information, if available	Images
Unauthorized Sexual Enhancement Products
Enhanced Vegetal Vigra capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration	Capsules
Extreme Diamond 3000	Undeclared desmethyl carbodenafil and dapoxetine	United States Food and Drug Administration
Gold Viagra capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration	Capsules
Gold Viagra tablets (packaged as "Kangaroo Sexually Invigorating Essence")	Undeclared sildenafil and tadalafil	Australian Therapeutic Goods Administration	Crescent-shaped, yellow tablets with 'Goldviagra' debossed on either side
Majestic Lovezone tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration	Tablets
Niu Mo Wang 'Bull Monster' tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration	Two-part product (foil-packaged tablets &  small round black pills in clear bag)
North West Wolf capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration	Capsules
Strong Horses capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration	Capsules
Strong-SX capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration	Capsules
USA Gold Ant capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration	Capsules
Unauthorized Weight Loss Products
Black Mamba Hyperrush	Undeclared sibutramine and phenolphthalein	United States Food and Drug Administration
Botanical Slimming (Red)	Undeclared fluoxetine	United States Food and Drug Administration
Green Algae Combination by Crane Beauty	Undeclared lorcaserin	United States Food and Drug Administration
Natural Max Slimming	Undeclared sildenafil, fluoxetine, and sibutramine	United States Food and Drug Administration	Capsules
OMG Slim capsules	Undeclared sibutramine and orlistat	Australian Therapeutic Goods Administration	Capsules
Skinny 22"	Undeclared phenolphthalein	Singapore Health Sciences Authority
Ultra ZX	Undeclared sibutramine and phenolphthalein	United States Food and Drug Administration
Ultimate Boost	Undeclared phenolphthalein	United States Food and Drug Administration	Capsules
Xcel	Undeclared fluoxetine	United States Food and Drug Administration	Capsules
Xcel Advanced	Undeclared phenolphthalein	United States Food and Drug Administration	Capsules

What you should do

• Contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if you find a product listed above in the Canadian marketplace.
• Consult with a healthcare professional if you have health concerns related to the use of any of these products.
• 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), Natural Product Number (NPN) or a Homeopathic Drug Number (DIN-HM).

Background

Prescription drugs should only be used under the supervision of a healthcare professional.

Dapoxetine is a prescription drug used to treat premature ejaculation and is not authorized for sale in Canada. Side effects include seizures, changes in blood pressure, blurred vision, dizziness, headache and nausea.

Desmethyl carbodenafil is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil should not 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 are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Fluoxetine is a prescription drug used to treat depression. Side effects include headache, sleeping problems, anxiety, nausea, loss of appetite and excessive sweating.

Lorcaserin is a prescription weight-loss drug that is not authorised for sale in Canada. Side effects include fatigue, headache, cough, sore throat, breathing difficulties, nausea, abdominal discomfort, back pain, irregular heartbeat, leg swelling, anxiety, mood change, and depression. In diabetic patients, severe low blood sugar may occur.

Orlistat is a prescription weight-loss drug. Side effects include abdominal discomfort, anal leakage, increased stool volume and frequency, and fatty/oily stool.

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

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil should not 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 are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Tadalafil is a prescription drug used to treat erectile dysfunction. Tadalafil should not 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 are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

As of June 23, 2015, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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