Health Canada

Health Canada

February 02, 2011 15:15 ET

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

OTTAWA, ONTARIO--(Marketwire - Feb. 2, 2011) -

The 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 website (http://www.loblaw.ca/en/abt_corprof.html) 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™ Multi Greens Powder" or "Exact™ Multi Greens Capsule"

What consumers 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).

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™ Multi Greens Powder (225 g): EN-142033

Exact™ Multi Greens Powder (510 g): EN-142033

Exact™ Multi Greens Capsules (360 capsules): EN-142032

Products affected:

"Exact™ Multi Greens Powder" and "Exact™ Multi Greens Capsule" 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 Capsule" is sold in containers of 360 capsules.

Photos of the products are available at the following address: http://media3.marketwire.com/docs/hlt-eng.pdf

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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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  (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_232-eng.php)

- Advisory (December 6, 2010) ─ "Probiophilus" and "Cultures de Yogourt 5 Milliards" May Pose Serious Health Risks to Canadians with Milk Allergies (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2010/2010_216-eng.php

- Warning (July 24, 2009) ─ Milk Allergy Risk Identified in the Natural Health Product: Dophilus Chewable Tablets (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_120-eng.php)

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories (http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/).

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709