Archived - V.MAX, Rhino Max (Rhino V Max)

Starting date:

April 13, 2007

Posting date:

April 13, 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-12000305

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

United States Food and Drug Administration

Product name

• V.MAX
• Rhino Max (Rhino V Max)

Manufacturer / Place of origin

• V.MAX: Barodon SF Incorporated, Los Angeles, California, United States of America
• Rhino Max (Rhino V Max): Cosmos Trading Incorporated, Los Angeles, California, United States of America

Product description

V.MAX and Rhino Max (Rhino V Max) are marketed as dietary supplements in the United States of America.

V.MAX is packaged with an outer box containing three smaller boxes each containing five capsules.

Rhino Max (Rhino V Max) is packaged in boxes containing five or 15 tablets.

Reason for warning

The United States Food and Drug Administration found V.MAX and Rhino Max (Rhino V Max) to contain undeclared amounts of aminotadalafil, an analogue of tadalafil, used to treat erectile dysfunction. Aminotadalafil is not intended to be used in self-care, and should only be taken under the guidance of a health professional.

Possible side effects

Aminotadalafil may have side effects including headache and flushing, and more serious effects such as severe hypotension (low blood pressure), and may potentially interact with nitrate-containing medications.

Individuals with diabetes, high blood pressure, high cholesterol, or heart disease who may be using nitrate-containing drugs may be at the greatest risk of adverse reactions with the use of V.MAX and Rhino Max (Rhino V Max), since these products are not labelled with the appropriate warnings of potential risks and contraindications for aminotadalafil.

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