Foreign Product Alert: Germany Black Gorilla tablets, Herbal Max Real Slim capsules, Kingdom Honey for Her, Majestic African Mango capsules, Maxidus capsules, RHINO 7 Platinum 5000, Royal Honey VIP, RUFF Natural Formula capsules, Sirrori Green Viagra...

Starting date:

October 27, 2017

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Identification number:

RA-64982

• 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.

Unauthorized Foreign Health Products

Product Name(s)	Hazard(s) Identified	Source of Alert	Images
Unauthorized Sexual Enhancement Products
Germany Black Gorilla tablets	Undeclared sildenafil	Australia Therapeutic Goods Administration
Kingdom Honey for Her	Undeclared tadalafil	United States Food and Drug Administration
Maxidus capsules	Undeclared sildenafil	Australia Therapeutic Goods Administration
RHINO 7 Platinum 5000	Undeclared sildenafil	United States Food and Drug Administration
Royal Honey VIP	Undeclared tadalafil	United States Food and Drug Administration
RUFF Natural Formula capsules	Undeclared tadalafil, sildenafil, dapoxetine	Australia Therapeutic Goods Administration
Sirrori Green Viagra tablets	Undeclared sildenafil	Australia Therapeutic Goods Administration
V8 tablets	Undeclared sildenafil	Australia Therapeutic Goods Administration
Unauthorized Weight Loss Products
Herbal Max Real Slim capsules	Undeclared sibutramine and phenolphthalein	Australia Therapeutic Goods Administration
Majestic African Mango capsules	Undeclared sibutramine and phenolphthalein	Australia Therapeutic Goods Administration

 

What you should do

• Contact Health Canada at 1-800-267-9675 or by completing an online complaint form if you find a product listed above in the Canadian marketplace.

• Consult 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 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. It is not authorized for sale in Canada. Side effects may include seizures, changes in blood pressure, blurred vision, dizziness, headache, and nausea.

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 people taking any kind of nitrate drug such as nitroglycerine because it can cause potentially life-threatening low blood pressure. People 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 people taking any kind of nitrate drug such as nitroglycerine as it can cause potentially life-threatening low blood pressure. People 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 for a health product to Health Canada:

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

As of September 19, 2017, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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