Synerate: Weight Loss Product Could Cause Serious Adverse reactions

Starting date:

January 7, 2011

Posting date:

January 7, 2011

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Identification number:

RA-15121

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing
• 
  Images

Issue

The product Synerate, manufactured for Strive and distributed by Upper 49th, is being voluntarily recalled from the Canadian market because of the risk of serious, potentially fatal adverse effects from the combination of the ingredients in the product.

Synerate, a product used for weight loss or body building, contains caffeine and synephrine, which is similar to ephedrine. When used in combination with caffeine and other stimulants, synephrine and/or ephedrine has caused reported adverse events ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke.

The product is not authorized by Health Canada and bears no Drug Identification Number (DIN), Natural Health Product Number (NPN), Homeopathic Medicine Number (DIN-HM) or Exemption Number (EN).

Products affected

Synerate

What you should do

• Consult your healthcare practitioner with any questions or concerns regarding use of this product.
• Read the label of 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 Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Some natural health products (NHPs) may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.
• Report any adverse reaction potentially related to this product to Health Canada (see below).

Who is affected

Canadians who have purchased or used the product Synerate manufactured for Strive and distributed by Upper 49th.

Background

Synerate products for sales were distributed by Upper 49th to retail stores earlier in 2010.  This product may also have been distributed as part of a kit with t-shirts as well as product samples.

Several health advisories have been issued by Health Canada warning Canadians about products containing synephrine/ephedrine/ephedra, in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy.

Report health or safety concerns

To report a suspected adverse reaction to these or other health products, please contact Heath 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

Media enquiries

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

Public enquiries

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.

What Health Canada is doing

Health Canada will monitor the voluntary recall conducted by Upper 49th.

Images

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