“U-Prosta”: herbal prostate product recalled as it may pose serious health risks

April 8, 2011

This is a reprint of the Health Canada alert.

Advisory
2011-54
April 7, 2011
For immediate release

The issue:

"U-Prosta Natural support for prostate health" is being voluntarily recalled in Canada by Sunnylife International Inc. after the U.S. Food and Drug Administration (FDA) found the product contains undeclared terazosin hydrochloride, which is a prescription drug used to treat high blood pressure and enlargement of the prostate gland, and could cause serious health effects. Prescription drugs should only be used under the supervision of a healthcare practitioner. "U-Prosta" is promoted as a natural health product used for prostate health.

Sunnylife International Inc. is based in Richmond, B.C. and has indicated that this product was sold at various natural health retail outlets located in western Canada. "U-Prosta" is also being voluntarily recalled in the U.S., by USA Far Ocean Group Inc.

Who is affected:

Consumers who have purchased or used "U-Prosta," particularly those who are also taking prescription medications for high blood pressure or enlarged prostate.

What consumers should do:

Speak to your healthcare practitioner about any health concerns regarding the use of this product.
Contact Sunnylife International Inc. directly for more information on the recall and how to return unused product: 1-604-247-1198
Report any adverse reaction potentially related to these products to Health Canada (see below).

What Health Canada is doing:

Following the U.S. FDA notification of the product recall in the U.S., Health Canada determined that "U-Prosta" was also being imported and sold in Canada by Sunnylife International Inc.

Sunnylife International Inc. issued a recall and stop-sale notice to its distributors and customers. Health Canada is monitoring the recall. Should additional importers be identified, Health Canada will take appropriate action and keep Canadians informed.

Background:

According to the U.S. FDA notice, the most likely adverse health consequences that could occur with the use of this product would be hypotension (low blood pressure), dizziness, or syncope (fainting). Headaches are also possible. Consumers who use "U-Prosta" and who are also taking prescription medications for high blood pressure or enlarged prostate would be at increased risk of these events. In these patients, the hypotensive events may be more severe.

Health Canada has not received any reports of adverse reactions involving "U-Prosta."

Consumers are encouraged to submit complaints regarding the sale of this or any other unapproved health product, or regarding the safety, efficacy or quality of a health product, by calling Health Canada's Inspectorate, toll-free, at 1-800-267-9675. For more information, see the guidance document "How to submit a consumer complaint (GUI-044)" available on the Health Canada website.

Products affected:

"U-Prosta" comes packaged in white plastic bottles of 30 capsules (UPC 689076499255), 60 capsules (UPC 88858100030), and in blister packs containing 1 capsule (no UPC).

A plastic bottle is shown here:

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

Fax: 1-866-678-6789
Internet: www.healthcanada.gc.ca/medeffect
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9