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Unapproved Health Product, UP Ultimate Performance For Men, May Pose Serious Health Risks

Starting date:
July 13, 2010
Posting date:
July 13, 2010
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Undeclared Substance, Unauthorized products
Audience:
General Public
Identification number:
RA-110003613

The issue

Health Canada is advising Canadians about UP Ultimate Performance for Men, an unauthorized health product promoted to enhance male sexual performance. This product has been found to contain undeclared sildenafil, a prescription medication that may pose serious and potentially life-threatening health risks, particularly to people with heart problems. Prescription medications should be taken under the supervision of healthcare practitioners. Vitality Research Inc. has agreed to voluntarily recall the unapproved health product from retail shelves and advises that it will no longer be selling the product in Canada.

Two additional unauthorized products: UP Ultimate Performance Daily Formula and UP Ultimate Performance for Women are of the same formulation and batch number as UP Ultimate Performance for Men and may also contain undeclared sildenafil. Vitality Research Inc. has agreed to also voluntarily recall these unapproved health products.

Who is affected

Canadians who have purchased or used UP Ultimate Performance for Men, UP Ultimate Performance Daily Formula and UP Ultimate Performance for Women, distributed by Vitality Research Inc., and at www.the-upline.com, particularly people with heart problems.

What consumers should do

  • Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
  • Read the labels on the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
  • Report any adverse reaction potentially related to these products to Health Canada (see below).

What Health Canada is doing

Health Canada is monitoring the distributor, Vitality Research Inc. and the company's recall of the products from the retail market and has been advised that the distributor has stopped selling the products.

Background

Sildenafil is used to treat erectile dysfunction and should be used only under the supervision of a health care practitioner. Products authorized for sale containing sildenafil indicate that it should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as this combination 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.

Products recalled/affected

  • Ultimate Performance for Men

The following products may also be affected and have been recalled:

  • UP Ultimate Performance Daily Formula
  • UP Ultimate Performance for Women

Note: all three products were sold in both bottle and baggie form, with similar labelling.

For more information

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products

To report a suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send it to us using one of these methods:

Related Health Canada Web Content


Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

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