Archived - Urat Madu

Starting date:

May 3, 2007

Posting date:

May 3, 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-12000319

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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

Singapore Health Sciences Authority

Product name

Urat Madu

Manufacturer / Place of origin

PJ. Air Madu (Malang, Indonesia)

Product description

The product Urat Madu is marketed as a treatment for erectile dysfunction. The red capsules are packaged in a small bag carrying the product name; the bag is packaged within a box also carrying the Urat Madu name.

Reason for warning

The Singapore Health Sciences Authority found Urat Madu capsules to be adulterated with the prescription drug sildenafil. Sildenafil citrate is indicated for the treatment of erectile dysfunction, and has been associated with serious adverse reactions.

Sildenafil is not intended for self-care, and should only be taken under the guidance of a health care professional.

Possible side effects

Consumers who use Urat Madu may be at risk of serious side effects associated with sildenafil, especially those patients with existing medical conditions such as heart problems, who are taking heart medications, or who may be at risk for strokes.

The serious side effects that have been associated with sildenafil include sudden vision loss, penile tissue damage and urinary tract infection.

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

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