Foreign Product Alert: Aphrodisiac capsules, Blue M, BMSW 4600MG Black Ant, Double Maxx D.B.M. capsules, HoliCare Metabolism Cleansing (MET-CLS) tablets, Horny Little Devil, Kopi Jantan Tradisional Natural Herbs Coffee, Life Rising Holder-W Holder Wa...
- Starting date:
- June 28, 2019
- Type of communication:
- Foreign Product Alert (FPA)
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Undeclared Substance
- Audience:
- General Public
- Identification number:
- RA-70319
Last updated:
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 Sexual Enhancement Products |
|||
|
Aphrodisiac capsules |
Undeclared sildenafil |
United States Food and Drug Administration |
|
|
Blue M |
Undeclared sildenafil and lignocaine |
Hong Kong Department of Health |
|
|
BMSW 4600MG Black Ant |
Undeclared sildenafil |
Australia Therapeutic Goods Administration |
|
|
Double Maxx D.B.M. capsules |
Undeclared sildenafil |
Australia Therapeutic Goods Administration |
|
|
Horny Little Devil |
Undeclared sildenafil and tadalafil |
Australia Therapeutic Goods Administration |
|
|
Kopi Jantan Tradisional Natural Herbs Coffee |
Undeclared sildenafil and tadalafil |
United States Food and Drug Administration |
|
|
Other Unauthorized Products |
|||
|
Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets |
High levels of lead |
United States Food and Drug 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.
Lead is a heavy metal that poses serious health risks. Ingestion of excessive amounts of lead may accumulate in vital organs of the body. Children are most susceptible to the toxic effects of heavy metals. The toxic effects of lead include abdominal pain, anemia, changes in blood pressure, reproductive disorders such as miscarriage, weakness, concentration problems, weight loss, insomnia, dizziness, and kidney and brain damage.
Lignocaine, also known as lidocaine, is a drug that is available with or without a prescription. It can be used as a local numbing agent or it can be injected intravenously to treat abnormal heart rhythms. Serious side effects include abnormal heartbeat, low blood pressure, breathing problems, agitation, confusion, seizure, and coma.
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., nitroglycerin) 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 a health or safety concern
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 29, 2019, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.
Images
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