Archived – Axcil and Desirin

Starting date:

November 28, 2007

Posting date:

November 28, 2007

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-12000284

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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 (FDA)

Product name

Axcil and Desirin

Manufacturer / Place of origin

Distributed by TWC Global, LLC, Inc., California, U.S.A.

Product description

Axcil and Desirin are promoted as natural sexual enhancement/erectile dysfunction products. Each product is packaged in 15-capsule blister packs enclosed in a box.

Reason for warning

The U.S. FDA warned consumers not to purchase or consume Axcil and Desirin because both products were found to contain sildenafil, a prescription drug used for the treatment of erectile dysfunction that should only be taken under the guidance of a health professional.

Possible side effects

Unsupervised use of sildenafil by patients with heart disease can result in serious cardiovascular side effects such as sudden cardiac death, heart attack, stroke, hypertension, chest pain and abnormal heartbeat. Additionally, use of sildenafil may be associated with other side effects including temporary vision loss, seizure, prolonged erection, headache, flushing, nasal congestion and abdominal pain. Sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerine) due to the risk of developing potentially life threatening low blood pressure.

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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