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 mg, Triple MiracleZen Plus 1500 mg, Triple Power Zen Gold 2000, Triple Power Zen Plus 2000, V-MAX Herbal Tablets, Xtra Zone 2200, Xtra Zone 2400, Xtra Zone 2600

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

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   Label, Lipo Escultura
Unauthorized Sexual Enhancement Products
100% healthy food for men tablets Undeclared sildenafil Australian Therapeutic Goods Administration   100% health food for men tablets pill packet front and back view
Blue Diamond capsules Undeclared sildenafil United States Food and Drug Administration   photo image of the Blue Diamond capsule packagingphoto image of the Blue Diamond capsule packaging
Diamond 3500 Undeclared sildenafil and tadalafil United States Food and Drug Administration   Image of Diamond 3500
Eros Power Zone 1900 Undeclared desmethyl carbodenafil and dapoxetine United States Food and Drug Administration   Image of Eros Power Zone 1900
OrgaZen 3500 Undeclared tadalafil United States Food and Drug Administration   Image of OrgaZen 3500
Rhino 7 Blue 9000 Undeclared tadalafil United States Food and Drug Administration   Image of Rhino 7 Blue 9000
Rhino Big Horn 3000 Undeclared desmethyl carbodenafil and sildenafil United States Food and Drug Administration   Image of Rhino Big Horn 3000
Triple MiracleZen Extreme 1750 mg Undeclared sildenafil , tadalafil and dapoxetine United States Food and Drug Administration   Image of Triple MiracleZen Extreme 1750
Triple MiracleZen Gold 1750 mg Undeclared sildenafil , tadalafil and dapoxetine United States Food and Drug Administration   Image of Triple MiracleZen Gold 1750
Triple MiracleZen Plus 1500 mg Undeclared sildenafil , tadalafil and dapoxetine United States Food and Drug Administration   Image of Triple MiracleZen Plus 1500
Triple Power Zen Gold 2000 Undeclared sildenafil and tadalafil United States Food and Drug Administration   Image of Triple Power Zen Gold 2000
Triple Power Zen Plus 2000 Undeclared sildenafil and tadalafil United States Food and Drug Administration   Image of Triple Power Zen Plus 2000
V-MAX Herbal Tablets Undeclared sildenafil Australian Therapeutic Goods Administration   Front and rear packaging of V-max tablets, and pill packet insert front and rear view
Xtra Zone 2200 Undeclared sildenafil and tadalafil United States Food and Drug Administration   Image of Xtra Zone 2200
Xtra Zone 2400 Undeclared sildenafil and tadalafil United States Food and Drug Administration   Image of Xtra Zone 2400
Xtra Zone 2600 Undeclared sildenafil and tadalafil United States Food and Drug Administration   Image of Xtra Zone 2600       

 

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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