OTTAWA, ONTARIO -- (Marketwired) -- 07/26/13 -- The issue:
Vita Health Products Inc., in consultation with Health Canada, is voluntarily recalling three lots of its Compliments Iron Ferrous Gluconate tablets (Product number: NPN 00582727; package of 100, 324 mg tablets) sold across Canada due to a labelling error. The company has identified that at least one bottle labelled as Compliments Iron Ferrous Gluconate 324 mg tablets actually contained Iron Ferrous Sulfate, 300 mg tablets, which poses a risk to adults with allergies to sulfate. To date, there have been no adverse reactions reported to Vita Health Products Inc. and Health Canada concerning these lots.
Who is affected:
Those with an allergy to sulfate are at risk.
What consumers should do
-- Consult their health care practitioner if they have used this product
and are concerned about their health.
-- Return the product to the place of purchase or call Vita Health Products
Inc. at 1-800-665-8820, Monday-Friday 9:00 a.m. - 5:30 p.m. EST for
further instruction.
-- Visit Vita Health Products Inc. recall notice for more information.
-- Report any adverse reactions to Health Canada.
-- Read the label of the products you buy to verify that they have been
assessed by Health Canada for safety, effectiveness and quality. Health
products that have been authorized for sale by Health Canada will have
an eight-digit Drug Identification Number (DIN), a Natural Product
Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
What Health Canada is doing:
Health Canada is monitoring Vita Health's recall and will inform Canadians if new information comes to light.
Products recalled/affected:
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Description Lot number Date of Manufacture Date of Expiry
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Compliments Iron 3B32630JA February 2013 December 2014
Ferrous Gluconate
324mg tablets,
100 Count
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2K00130JA November 2012 September 2014
---------------------------------------------------------
3E31332R9 May 2013 March 2015
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Photos of the products are available at the following address: http://media3.marketwire.com/docs/vita.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.
More information is also available from Vita Health Inc. by calling 1-800-665-8820, Monday-Friday 9am-5:30 pm EST.
How to report side effects to Health Canada:
-- Call toll-free at 1-866-234-2345
-- Visit MedEffect Canada's web page on Adverse Reaction Reporting for
information on how to report online, by mail or by fax.
Related Health Canada Web content:
-- Information Update (April 18, 2012): Compliments Extra Strength
Acetaminophen Gelcaps Labelling Error: May Cause Serious Harm to
Children
-- Recall Notice (April 30, 2012): Compliments Extra Strength Acetaminophen
-- Information Update (December 29, 2011): "Compliments Muscle and Back
Pain Relief Regular Strength": Labelling Error May Pose Serious Risks to
Children
-- Recall Notice (January 9, 2012): Exact, Compliments, PhSv One Tablet
Daily Weight Wise
-- Recall Notice (March 7, 2011): Equate Children's Gummy Multivitamins
Compliments, Children's Gummy Multivitamins Truly, Children's Gummy
Multivitamins
-- Recall Notice (March 7, 2011): Kirkland Omega Gummies Equate Omega
Gummies Compliments Omega Gummies
-- Recall Notice (April 26, 2010): Equate Ferrous Sulfate Compliments
Ferrous Sulfate Overwaitea Ferrous Sulfate Truly Ferrous Sulfate
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
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Contacts:
Media Inquiries:
Health Canada
613-957-2983
Public Inquiries:
613-957-2991
1-866-225-0709
