Nite Rider Maximum Sexual Enhancer for Men, STUD Capsule for Men

Starting date:

March 22, 2011

Posting date:

March 22, 2011

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-120001663

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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

U.S. Food and Drug Administration

Product names

• Nite Rider Maximum Sexual Enhancer for Men
• STUD Capsule for Men

Manufacturer / Place of origin

Kanec U.S.A. Inc. of Davie, Florida, U.S.A.

Product description

These products are promoted as dietary supplements used for sexual enhancement. They come packaged in a blister pack of one capsule per unit of use, 24 packets in a display box.

Reason for warning

The U.S. FDA informed consumers of a company recall of these products after they were found to contain undeclared sildenafil.

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

According to the company news release, the products were distributed to wholesalers in Florida, U.S.A. Health Canada has issued a previous Foreign Product Alert for STUD Capsule for Men.

Possible side effects

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 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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