Stallion, SZM Formula for Men, Tomcat Ali and Volcanic

Starting date:

July 14, 2010

Posting date:

July 14, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance

Audience:

General Public

Identification number:

RA-120001229

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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.

Source of alert

New Zealand MedSafe

Product names

• Stallion
• SZM Formula for Men
• Tomcat Ali
• Volcanic

Manufacturer / Place of origin

Unknown

Product description

These four products are promoted for the treatment erectile dysfunction or to improve male sexual performance.

Reason for warning

New Zealand's Medsafe warned consumers to not buy or use these four products after they were found to contain undeclared tadalafil.

Tadalafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a health care practitioner. Medsafe ordered the immediate recall of all product batches. Consumers were advised to immediately stop taking these products and to seek medical attention if they were taking other medications or if they felt unwell while using these products.

Yohimbine is a prescription drug that can affect blood pressure and the heart. It should only be taken under the supervision of a health care practitioner.

Indomethacin is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Indomethacin should only be taken under the supervision of a health care practitioner.

Sildenafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a health care practitioner.

Possible side effects

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 from tadalafil use such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

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.

Background

Drugs and natural health products that are authorized for sale in Canada will have either 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 the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• 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

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866 225-0709

Images

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