Archived – Oyster Plus

Starting date:

September 21, 2007

Posting date:

September 21, 2007

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-12000214

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

Malaysian Ministry of Health

Product name

Oyster Plus

Manufacturer / Place of origin

Unknown Manufacturer / Imported into Malaysia from China

Product description

Oyster Plus was an approved sexual enhancement/erectile dysfunction product in Malaysia.

Reason for warning

The Malaysian Ministry of Health cancelled the registration of the product Oyster Plus due to the presence of tadalafil, 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 tadalafil 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 tadalafil may be associated with other side effects including temporary vision loss, seizure, prolonged erection, headache, flushing, nasal congestion and abdominal pain. Tadalafil 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