Foreign Product Alerts: Volcano Male Enhancement Liquid, and Volcano Male Enhancement Capsules
- Starting date:
- April 24, 2014
- Posting date:
- April 24, 2014
- Type of communication:
- Foreign Product Alert (FPA)
- Drugs, Natural health products
- Source of recall:
- Health Canada
- Source of alert:
U.S. Food and Drug Administration
- Undeclared Substance
- General Public
- Identification number:
These 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.
- Volcano Male Enhancement Liquid
- Volcano Male Enhancement Capsules
Volcano Male Enhancement Liquid, and Volcano Male Enhancement Capsules
These products are promoted for sexual enhancement.
The recalled products are Volcano Male Enhancement Liquid (2 oz bottle), UPC 609613859960, LOT 301, distributed from January 1, 2013 to July 2013, and Volcano Male Enhancement Capsules (black or white round plastic pop top container with 1 capsule inside), UPC 609613859977, LOT 7455.
The U.S. Food and Drug Administration warned consumers not to use these products after they were found to contain desmethyl carbodenafil, dimethylsildenafil and dapoxetine, drug ingredients that were not declared on the product label.
Desmethyl carbodenafil and dimethylsildenafil are unauthorized substances that may be similar to prescription drugs used to treat erectile dysfunction and may pose similar health risks. Prescription drugs should only be taken under the supervision of a healthcare professional.
Dapoxetine is a prescription drug used to treat premature ejaculation and is not authorized for sale in Canada.
Place of origin
Volcano Company of Long Beach, California, USA.
Erectile dysfunction drugs should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they 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.
Side effects associated with dapoxetine include seizures, changes in blood pressure, blurred vision, dizziness, headache and nausea.
What you should do
Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.
Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of these products.
Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.
As of April 4, 2014, no adverse reactions suspected to be associated with the use of these products had been reported to Health Canada.
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
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