|By Marketwired .||
|October 10, 2013 07:26 PM EDT||
OTTAWA, ONTARIO -- (Marketwired) -- 10/10/13 --
This document corrects and replaces the press release that was sent today at 6:04 PM ET
Adeeva Nutritionals Inc., in consultation with Health Canada, is voluntarily recalling its natural health product "Flora Essentials" - a digestive aid - due to a possible contamination with chloramphenicol, an antibiotic that may pose serious health risks to consumers. Chloramphenicol is associated with a rare risk of aplastic anemia, a serious blood disorder that can be fatal. This reaction is unpredictable and not related to a specific dose of chloramphenicol.
Chloramphenicol is a prescription drug and should only be used under medical supervision in adults and children after careful consideration of the risks associated with it use. Other side effects that can be associated with chloramphenicol include allergic reactions in people who have sensitivity to the medication, and effects on the bone marrow leading to decreased blood cells. In addition, it should not be used in pregnant or lactating women.
Who is affected: Canadians who have used this product. The company and Health Canada have not received any reports of adverse reactions associated with this product.
What consumers should do:
-- Consult your healthcare practitioner immediately if you have used this product. -- Report any adverse events using this product to Health Canada. -- Contact Adeeva Nutritionals Inc. at 1-888-251-1010 (ext. 1014) to return the product.
What Health Canada is doing:
Health Canada is monitoring the recall of "Flora Essential" by the company.
According to the company, testing of one of the raw materials used to produce this product identified the presence of chloramphenicol.
1. Flora Essentials (NPN 80039819) Lot #10342
Flora Essentials - Outer package: http://media3.marketwire.com/docs/adeeva1010.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 and send to us using one of these methods:
Fax: 1-866-678-6789 Internet: http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php Mail: Canada Vigilance Program Marketed Health Products Directorate Ottawa, ON, Address Locator 0701E K1A 0K9
Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools.
Egalement disponible en francais
Media Enquiries: Health Canada