U-Prosta: Herbal Prostate Product Recalled as It May Pose Serious Health Risks

Starting date:

April 7, 2011

Posting date:

April 7, 2011

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-110004949

• 
  Reason
• 
  What you should do
• 
  Depth of distribution
• 
  Who is affected
• 
  Background
• 
  Affected products
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

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.

Reason

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.

What you 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).

 

Depth of distribution

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.

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.

Affected products

Report health or safety concerns

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:

• Facsimile: 1-866-678-6789
• Internet: MedEffect Canada
• Mail: Canada Vigilance Program
  
  Marketed Health Products Directorate
  
  Ottawa, ON, Address Locator 0701E
  
  K1A 0K9

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709

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.

Images

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