Foreign Product Alert: 3rd Degree, Black Gold X Advanced, The Body Shot Bar Step 2, Black Label X, Super Dragon capsules, Lang Yi Hao Tablets, Hai Leng Hai Beh Herbal Itch Removing Capsule

Starting date:

July 13, 2016

Posting date:

July 13, 2016

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-59336

• 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.

Product Name(s)	Hazard(s) Identified	Source of Alert	Images
Unauthorized Weight Loss Products
3rd Degree	Undeclared sibutramine	United States Food and Drug Administration
Black Gold X Advanced	Undeclared sibutramine	United States Food and Drug Administration
The Body Shot Bar Step 2	Undeclared sibutramine	United States Food and Drug Administration
Black Label X	Undeclared sildenafil	United States Food and Drug Administration
Unauthorized Sexual Enhancement Products
Super Dragon Capsules (The outer carton refers to Dragon; however the name on the blister pack is Super Dragon)	Undeclared sildenafil	Australian Therapeutic Goods Administration
Lang Yi Hao Tablets	Undeclared sildenafil, chloramphenicol	Australian Therapeutic Goods Administration
Other Unauthorized Products
Hai Leng Hai Beh Herbal Itch Removing Capsule	Undeclared dexamethasone, chlorpheniramine, paracetamol	Singapore Health Sciences Authority

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.

Chloramphenicol is a prescription antibiotic drug.  Side effects include abdominal pain, allergic reactions, and bone marrow failure (aplastic anemia).

Chlorpheniramine 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.  It should only be taken under the supervision of a healthcare professional. Side effects associated with dexamethasone 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 dexamethasone may cause symptoms of withdrawal.

Paracetamol, also known as acetaminophen, is an ingredient used in both non-prescription and prescription drugs to treat fever and pain. Long-term use of high doses of acetaminophen may cause serious liver damage.

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 July 12, 2016 no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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