Foreign Product Alert: Black Panther, King of Romance, MMC USA Blue Shark capsules, Viagra 007, beFIT Total Garcinia Cambogia, Fatloss Slimming Beauty, Li Da Dai Dai Hua Slimming Capsule, Slim Forte Slimming Capsule, Superior, Asihuri Plus Forte, Jia...

Starting date:

August 14, 2015

Posting date:

August 14, 2015

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Undeclared Substance, Important Safety Information

Audience:

General Public

Identification number:

RA-54644

• 
  Issue
• 
  What you should do
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  Report health or safety concerns
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  Images

Issue

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients or high levels of heavy metals.

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.

Product Name(s)	Hazard(s) Identified	Source of Alert	Other product information, if available	Images
Unauthorized Sexual Enhancement Products
Black Panther	Undeclared sildenafil	United States Food and Drug Administration
King of Romance	Undeclared sildenafil	United States Food and Drug Administration
MMC USA Blue Shark capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration	Capsules
Viagra 007	Undeclared sildenafil	United States Food and Drug Administration
Unauthorized Weight Loss Products
beFIT Total Garcinia Cambogia	Undeclared sibutramine and phenolphthalein	Singapore Health Science Authority
Fatloss Slimming Beauty	Undeclared sildenafil	United States Food and Drug Administration	Capsules
Li Da Dai Dai Hua Slimming Capsule	Undeclared sibutramine	United States Food and Drug Administration	Capsules
Slim Forte Slimming Capsule	Undeclared sibutramine	United States Food and Drug Administration	Capsules
Superior	Undeclared sibutramine	United States Food and Drug Administration
Unauthorized Pain Relief Products
Asihuri Plus Forte	Undeclared dexamethasone and phenylbutazone	United States Food and Drug Administration
Jianbu Huqian Wan	Undeclared dexamethasone, chlorpheniramine, and furosemide	United States Food and Drug Administration
Ginseng She Lian Wan	Undeclared dexamethasone and chlorpheniramine	United States Food and Drug Administration
Saurean Fong Sep Lin	Undeclared dexamethasone and cyproheptadine	United States Food and Drug Administration
Pyrola Advanced Joint Formula	Undeclared diclofenac and chlorpheniramine	United States Food and Drug Administration
Other Unauthorized Products
Jiedu tablets, high strength – bottle of 60	Undeclared arsenic	Australian Therapeutic Goods Administration	Tablets

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.

Arsenic is a heavy metal that poses serious health risks when an excessive amount is ingested because it may accumulate in vital organs of the body.  Children are most susceptible to the toxic effects of heavy metals.  The toxic effects of arsenic include skin and lung cancers, heart and lung diseases, and brain damage. 

Chlorpheniramine is a non-prescription antihistamine drug. Side effects include drowsiness, dizziness, confusion and blurred vision.

Cyproheptadine is a non-prescription antihistamine drug. Side effects include drowsiness, dizziness, confusion and blurred vision.

Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. Side effects include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders. Consult with your healthcare professional prior to stopping use, as sudden discontinuation of this drug may cause symptoms of withdrawal.

Diclofenac is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Side effects include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure, and reduced blood clotting ability.

Furosemide is a prescription diuretic (water pill) used to remove excess fluid from the body. Side effects include changes in electrolytes (specifically potassium), muscle cramps, dizziness, low blood pressure, 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.

Phenylbutazone was previously used to treat pain, fever, and inflammation, but is no longer authorized for sale in Canada because of its association with bone marrow suppression, which makes the body unable to fight infection.  Additional side effects include reduced blood clotting ability, gastrointestinal bleeding and kidney failure.

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.

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 August 11, 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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