Archived – STEAM – Lot # 80214, 90260

Starting date:

October 14, 2009

Posting date:

October 14, 2009

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Unauthorized products

Audience:

General Public

Identification number:

RA-12000942

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 name

• STEAM - Lot # 80214, 90260

Manufacturer / Place of origin

Nutracoastal Trading LLC, Freeport, New York, USA

Product description

STEAM is promoted as a dietary supplement used for the treatment of erectile dysfunction. It is sold in white plastic bottles of 5 capsules.

Reason for warning

The U.S. Food and Drug Administration (FDA) informed consumers of a voluntary manufacturer recall of two lots of STEAM after FDA testing found these lots to contain undeclared sulfoaildenafil (lot# 80214) and undeclared tadalafil (lot# 90260). Sulfoaildenafil is an unauthorized substance similar to sildenafil. Tadalafil and sildenafil are prescription drugs used to treat erectile dysfunction. They should only be taken under the supervision of a health care practitioner.

Possible side effects

Tadalafil and sildenafil should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they 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