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

Advisory
2011-17
February 2, 2011 (revised February 3, 2011)
For immediate release

The issue:

"Exact^TM Multi Greens Powder" and "Exact^TM 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^TM is the store brand of Loblaws grocery chains (See Loblaw website 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.

Who is affected:

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

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.

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

For more information:

ConsConsumers 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 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

Related Health Canada Web content:

• Advisory (December 24, 2010): Update: Four Probiotic Natural Health Products May Pose Serious Health Risks to Canadians with Milk or Soy Allergies
• Advisory (December 6, 2010) - "Probiophilus" and "Cultures de Yogourt 5 Milliards" May Pose Serious Health Risks to Canadians with Milk Allergies
• Warning (July 24, 2009) - Milk Allergy Risk Identified in the Natural Health Product: Dophilus Chewable Tablets

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Media Enquiries:
Health Canada
(613) 957-2983

Public Enquiries:
(613) 957-2991
1-866 225-0709