Vigor-25 and Man Up Now

Starting date:

January 31, 2011

Posting date:

January 31, 2011

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-120001614

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

• Vigor-25
• Man Up Now

Manufacturer / Place of origin

Vigor-25 is distributed by Piston Corp. Man Up Now is distributed by Synergy Distribution LLC.

Product description

Vigor-25 is promoted as a natural "male sexual stimulant". Man Up Now is promoted as an "herbal" and "all natural" dietary supplement used for sexual enhancement. It comes as a capsule packaged in single, double, and triple blister packs, and in 6-, 12-, and 30-count capsule bottles.

Reason for warning

The U.S. FDA warned consumers not to buy or use Vigor-25 or Man Up Now because Vigor-25 contains undeclared sildenafil while Man Up Now contains undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil and may pose similar heath risks.

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

According to the U.S FDA news releases, these products are sold on Internet sites and possibly in some U.S. retail outlets. The FDA also confirmed in its release regarding Vigor-25 that it is investigating the reported death of a 26-year old man, possibly associated with the use of Vigor-25.

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