Foreign Product Alert: Maxman Cialis tablets, Black King Kong, Tibet Babao, Vigour 300, Hard Wang, FX3000, Sex Men, Vigra, Plant Vigra, Santi Scalper, Baolong, Rhino Blitz Gold 3000, Vim-25, Black Mamba Premium, Bigger Longer More Time More Sperms (s...

Starting date:

May 15, 2015

Posting date:

May 15, 2015

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance, Unauthorized products

Audience:

General Public

Identification number:

RA-53415

• Issue
• What you should do
• Background
• 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.

Affected products

Product Name(s)	Hazard(s) Identified	Source of Alert	Other product information, if available	Images
Unauthorized Sexual Enhancement Products
Maxman Cialis tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration	Tablets
Black King Kong	Undeclared sildenafil	United States Food and Drug Administration
Tibet Babao	Undeclared sildenafil	United States Food and Drug Administration
Vigour 300	Undeclared sildenafil	United States Food and Drug Administration
Hard Wang	Undeclared sildenafil	United States Food and Drug Administration
FX3000	Undeclared sildenafil	United States Food and Drug Administration
Sex Men	Undeclared sildenafil	United States Food and Drug Administration
Vigra	Undeclared sildenafil	United States Food and Drug Administration
Plant Vigra	Undeclared sildenafil	United States Food and Drug Administration
Santi Scalper	Undeclared sildenafil	United States Food and Drug Administration
Baolong	Undeclared sildenafil	United States Food and Drug Administration
Rhino Blitz Gold 3000	Undeclared sildenafil	United States Food and Drug Administration
Vim-25	Undeclared sildenafil	United States Food and Drug Administration	Capsule
Black Mamba Premium	Undeclared sildenafil	United States Food and Drug Administration
Bigger Longer More Time More Sperms (sic)	Undeclared sildenafil	United States Food and Drug Administration
Herb Viagra	Undeclared sildenafil	United States Food and Drug Administration
La Pepa Negra	Undeclared sildenafil	United States Food and Drug Administration
Male Silkworm Moth Nourishing Oral Liquid	Undeclared vardenafil	United States Food and Drug Administration
Unauthorized Weight Loss Products
Nine Slim	Undeclared  phenolphthalein	United States Food and Drug Administration
Seven Slim	Undeclared  phenolphthalein	United States Food and Drug Administration
Oxy ELITE Pro Super Thermogenic	Undeclared  fluoxetine	United States Food and Drug Administration
Elimulating Weight & Toxin Keeping Beauty	Undeclared sibutramine	United States Food and Drug Administration
L-Carnitine Sob Strengthening Version Slimming Miracle Capsule	Undeclared sibutramine	United States Food and Drug Administration	Capsule
Lean Body Extreme	Undeclared sibutramine Undeclared desmethyl sibutramine Undeclared phenolphthalein Undeclared sildenafil	United States Food and Drug Administration	Capsules
Diablos Eca Fire Caps	Undeclared sildenafil Undeclared phenolphthalein Undeclared sibutramine Undeclared deisobutylbenzylsibutramine	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.

Desmethyl sibutramine is an unauthorized substance similar to sibutramine and may pose similar health risks. 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. In addition to heart attack and stroke, side effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Deisobutylbenzylsibutramine is an unauthorized substance similar to sibutramine and may pose similar health risks. 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. In addition to heart attack and stroke, side effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

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

Phenolphthalein was previously used as a laxative but 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.

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. In addition to heart attack and stroke, side effects associated with sibutramine 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.

Vardenafil is a prescription drug used to treat erectile dysfunction.  Vardenafil 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 May 4, 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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