Health Canada

Health Canada

May 04, 2011 11:37 ET

"Omega Alpha Kidney Flush" Being Recalled from the Canadian Market: May Cause Serious Adverse Reactions in Pregnant Women and Kidney Disease Patients

OTTAWA, ONTARIO--(Marketwire - May 4, 2011) -

The issue:

Omega Alpha Pharmaceuticals Inc., in consultation with Health Canada, is voluntarily recalling (http://www.omegaalpha.ca/en/resources/9/Media_Release/) all lots of "Omega Alpha Kidney Flush" due to the omission of cautionary and warning statements on the product label. This recall involves all lots of "Omega Alpha Kidney Flush" product, under the Omega Alpha brand, sold at retail locations in Ontario, Québec, British Columbia and Alberta.

Due to the combination of medicinal ingredients, this product is for occasional use only and should not be taken for extended periods of time. In addition, this product may present risks to the health of certain vulnerable populations, such as individuals with cardiovascular disease, kidney, high blood pressure, liver or gall bladder disorders, allergies to plants of the Poaceae and/or Asteraceae/Compositae family as well as pregnant and/or breast-feeding women.

Who is affected:

Canadians who have purchased or used "Omega Alpha Kidney Flush", specifically pregnant women and consumers with kidney disease.

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).

  • Contact Omega Alpha Pharmaceuticals Inc. (Toronto, Ontario) at 1-800-651-3172 .

  • Return the product to the place of purchase, the retail location or directly to Omega Alpha Pharmaceuticals Inc., for a full refund.

What Health Canada is doing:

Health Canada is monitoring the recall of "Omega Alpha Kidney Flush" from the Canadian market. Should any new information be identified, Health Canada will continue to provide an update to Canadians.

Background:

Omega Alpha Pharmaceuticals Inc. has stopped the sale of "Omega Alpha Kidney Flush" and is following-up with their retailers. The company is also advising consumers to return the product, either to the place of purchase or directly to them, for a refund. Any new product being sold will contain all the risk information in accordance with the product licence (NPN 80023986) issued by Health Canada. Further information on the product licence for this product is available in the Licensed Natural Health Products Database (http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php) by searching under the NPN number.

Products affected:

1. Kidney Flush, UPC code 826913121805.

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:

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

    Public Inquiries:
    613-957-2991
    1-866-225-0709