Vita Health Products Inc. Compliments Iron Ferrous Gluconate Tablets Pose Risk to Those with Allergies to Sulfate

Starting date:
July 26, 2013
Posting date:
July 26, 2013
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Allergy Information, Labelling and Packaging
Audience:
General Public
Identification number:
RA-34785

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.

Products recalled/affected
Description Lot number Date of Manufacture Date of Expiry
Compliments Iron Ferrous Gluconate 324mg tablets, 100 Count 3B32630JA February 2013 December 2014
2K00130JA November 2012 September 2014
3E31332R9 May 2013 March 2015

What you 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. recallor 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.

Who is affected

Those with an allergy to sulfate are at risk.

Report health or safety concerns

  • 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.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring Vita Health's recall and will inform Canadians if new information comes to light.

Images

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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.

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