Vialipro

Starting date:

September 20, 2010

Posting date:

September 20, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Source of alert:

U.S. Food and Drug Administration (FDA)

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-120001292

These products are not authorized for sale in Canada and have not been found in the Canadianmarketplace, 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 (FDA)

Product Names

Vialipro - Affected lots:

• 80409 - Capsules, 10 Count - All Dates
• 80661 - Capsules, 10 Count - All Dates
• 81146 - Capsules, 10 Count - All Dates
• 90132 - Capsules, 10 Count - All Dates
• 90265 - Capsules, 10 Count - All Dates
• 90587 - Capsules, 10 Count - All Dates
• 90826 - Capsules, 10 Count - All Dates
• 91065 - Capsules, 10 Count - All Dates
• 00197 - Capsules, 10 Count - All Dates
• 00347 - Capsules, 10 Count - All Dates

Manufacturer / Place of Origin

Good Health, Inc. of Canutillo, Texas, U.S.

Reason for Warning

The U.S. FDA informed consumers of a recall of certain lots (see lot numbers listed above) of Vialipro after FDA tests found product samples to contain undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction and should only be taken under the supervision of a health care practitioner. The lots are being voluntarily recalled nationwide in the U.S. by the company Good Health, Inc. According to the company-issued news release, consumers are advised to stop using the product and return it to Good Health, Inc. Consumers and distributors can contact the company at 1 (866) 607-0338 for more information on the recall.

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