Foreign Product Alert: Samurai-X, Happy Passengers, Top Gun for Men tablets, Power 1 tablets, Maxman Domina Tu Pareja tablets, Yanhee Slim, EDGE Amplified Weight Release, iNDiGO, AMPD Gold Bee Pollen, BtRim Max, iNSANE Bee Pollen, and Dr. Ming's Chin...

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-53413

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
Unauthorized Sexual Enhancement Products
Samurai-X	Undeclared sildenafil	United States Food and Drug Administration	Capsules
Happy Passengers	Undeclared sildenafil	United States Food and Drug Administration
Top Gun for Men tablets	Undeclared tadalafil	Australian Therapeutic Goods Administration	Blister tray with two tablets
Power 1 tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration	Tablets
Maxman Domina Tu Pareja tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration	Tablets
Unauthorized Weight Loss Products
Yanhee Slim	Undeclared lorcaserin	United States Food and Drug Administration
EDGE Amplified Weight Release	Undeclared phenolphthalein and fluoxetine	United States Food and Drug Administration	Capsules
iNDiGO	Undeclared phenolphthalein	United States Food and Drug Administration	Capsules
AMPD Gold Bee Pollen	Undeclared sildenafil	United States Food and Drug Administration	Capsules
BtRim Max	Undeclared phenolphthalein	United States Food and Drug Administration	Capsules
iNSANE Bee Pollen	Undeclared phenolphthalein and fluoxetine	United States Food and Drug Administration	Capsules
Other Unauthorized Products
Dr. Ming's Chinese capsule	Undeclared sildenafil	Australian Therapeutic Goods 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.

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.

Lorcaserin is a prescription weight-loss drug that is not authorised for sale in Canada. Side-effects associated with lorcaserin 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.

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.

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 May 5, 2015, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.