Exact™ Multi Greens Powder and Capsules Recalled as They May Pose Serious Health Risks to Canadians with Milk Allergies

Starting date:

February 2, 2011

Posting date:

February 2, 2011

Type of communication:

Advisory

Subcategory:

Allergen - Milk, Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Allergy Information

Audience:

General Public, Healthcare Professionals

Identification number:

RA-110004839

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

Issue

Exact™ Multi Greens Powder and Exact™ Multi Greens Capsule are being voluntarily recalled by Pharmetics Inc. because of an allergy risk to people with milk sensitivities. The natural health products are labelled as not containing dairy (milk), but they may contain trace amounts of milk protein from ingredients used in the production process. Exact™ is the store brand of Loblaws grocery chains (see Loblaw web site for the list of stores).

People with milk allergies can experience a range of mild to severe symptoms when exposed to even small amounts of milk proteins. Symptoms may include breathing difficulties that, in some cases, can be life threatening. Health Canada has received no reports of adverse reactions involving these products to date.

Products affected

Exact™ Multi Greens Powder and Exact™ Multi Greens Capsules are natural health products that contain live bacteria (probiotics) for therapeutic purposes.

Exact™ Multi Greens Powder is sold in 225 g and 510 g containers, while Exact™ Multi Greens Capsules are sold in containers of 360 capsules.

What you should do

• Speak to your healthcare practitioner with any questions or concerns regarding further use of these products.
• Report any adverse reaction potentially related to these products to Health Canada (see below).

Who is affected

Canadians with milk allergies who have purchased or used Exact™ Multi Greens Powder or Exact™ Multi Greens Capsule.

Background

Live microorganisms, including probiotics, that are included in natural health products are grown in nutrient solutions called culture media. The culture media used to produce probiotics include a source of protein, which is frequently but not always derived from milk, which is a priority allergen in Canada. For products that are formulated as pills or dry powders, the culture media is mostly removed before freeze-drying. Because culture media is removed, it is not considered to be a non-medicinal ingredient and is not required to be listed on product labels. However, traces of milk or any other priority allergen included in culture media that was removed can remain in the product in quantities sufficient to provoke an allergic reaction in highly sensitive individuals.

Products that have been assessed by Health Canada for safety, effectiveness and quality 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 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. The products being recalled have ENs, as follows:

• Exact™ Multi Greens Powder (225 g): EN-142033
• Exact™ Multi Greens Powder (510 g): EN-142033
• Exact™ Multi Greens Capsules (360 capsules): EN-142032

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:

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

Related AWRs

Brewer's Yeast Tablets: May pose serious health risks to Canadians with milk allergies

2011-10-25 | Health products

Advisory

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 recalls. Pharmetics Inc. has confirmed to Health Canada that these products are discontinued; however, some may remain on store shelves or in homes.

Images

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