Foreign Product Alert: Lipo Escultura, 100% healthy food for men tablets, Blue Diamond capsules, Diamond 3500, Eros Power Zone 1900, OrgaZen 3500, Rhino 7 Blue 9000, Rhino Big Horn 3000, Triple MiracleZen Extreme 1750 mg, Triple MiracleZen Gold 1750 ...

Starting date:

March 29, 2016

Posting date:

March 29, 2016

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Unauthorized products, Important Safety Information

Audience:

General Public

Identification number:

RA-57694

• Issue
• What you should do
• 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 Weight Loss Products
Lipo Escultura	Undeclared sibutramine	United States Food and Drug Administration
Unauthorized Sexual Enhancement Products
100% healthy food for men tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration
Blue Diamond capsules	Undeclared sildenafil	United States Food and Drug Administration
Diamond 3500	Undeclared sildenafil and tadalafil	United States Food and Drug Administration
Eros Power Zone 1900	Undeclared desmethyl carbodenafil and dapoxetine	United States Food and Drug Administration
OrgaZen 3500	Undeclared tadalafil	United States Food and Drug Administration
Rhino 7 Blue 9000	Undeclared tadalafil	United States Food and Drug Administration
Rhino Big Horn 3000	Undeclared desmethyl carbodenafil and sildenafil	United States Food and Drug Administration
Triple MiracleZen Extreme 1750 mg	Undeclared sildenafil , tadalafil and dapoxetine	United States Food and Drug Administration
Triple MiracleZen Gold 1750 mg	Undeclared sildenafil , tadalafil and dapoxetine	United States Food and Drug Administration
Triple MiracleZen Plus 1500 mg	Undeclared sildenafil , tadalafil and dapoxetine	United States Food and Drug Administration
Triple Power Zen Gold 2000	Undeclared sildenafil and tadalafil	United States Food and Drug Administration
Triple Power Zen Plus 2000	Undeclared sildenafil and tadalafil	United States Food and Drug Administration
V-MAX Herbal Tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration
Xtra Zone 2200	Undeclared sildenafil and tadalafil	United States Food and Drug Administration
Xtra Zone 2400	Undeclared sildenafil and tadalafil	United States Food and Drug Administration
Xtra Zone 2600	Undeclared sildenafil and tadalafil	United States Food and Drug Administration

 

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.

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.

Images

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