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Foreign Product Alert: Golden Root Complex Capsules, Bushen Famous Men Capsules, Laopiaoke Capsules, Akttive Capsules, and Zero Xtreme Capsules
- Starting date:
- August 26, 2015
- Posting date:
- August 26, 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-54820
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 | Other product information, if available | Images |
|---|---|---|---|---|
| Unauthorized Sexual Enhancement Products | ||||
| Golden Root Complex Capsules | Undeclared sildenafil | Australian Therapeutic Goods Administration |
|
|
| Bushen Famous Men Capsules | Undeclared sildenafil | Australian Therapeutic Goods Administration | Package contains 8 capsules and 8 pills |
|
| Laopiaoke Capsules | Undeclared sildenafil | Australian Therapeutic Goods Administration |
|
|
| Unauthorized Weight Loss Products | ||||
| Akttive Capsules | Undeclared sibutramine, desmethylsibutramine, and phenolphthalein | United States Food and Drug Administration |
|
|
| Zero Xtreme Capsules | Undeclared sibutramine and desmethylsibutramine | United States Food and Drug Administration |
|
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.
Desmethylsibutramine is an unauthorized substance similar to sibutramine and may pose similar health risks. 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.
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 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 18, 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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