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Allergy Sinus Medications Recalled Due to a Labeling Error

Aug 30 2013 12:00AM



OTTAWA, ONTARIO -- (Marketwired) -- 08/30/13 -- Vita Health Products Inc., in consultation with Health Canada, is voluntarily recalling certain lots of "Life", "Exact", "Rexall" and "Tanta" brands of its Extra Strength Allergy Sinus Medication due to a labeling error. The warning statement to not use these products if you have chronic lung disease is missing from the inner printing on the outer carton.

The tablets contain acetaminophen, pseudoephedrine HCL and chlorpheniramine maleate. The chronic lung disease warning is required for chlorpherinamine maleate because it is an antihistamine that may cause breathing problems.

Vita Health Products Inc. is reviewing additional products and taking actions to address the labelling issues. Health Canada has not received any information suggesting the quality of the products has been affected. Health Canada will inform Canadians if new information comes to light.

Health Canada has been advised by Vita Health Products Inc. that as of August 14, 2013, there have been no adverse reactions reported to Vita Health Products Inc. concerning these products. As of August 19, 2013, there have been no adverse reactions reported to Health Canada concerning these specific products.

If you have used or purchased a Vita Health product listed below and are concerned about its impact on your health, please consult your healthcare practitioner. Consumers are also encouraged to 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.

Health Canada is monitoring the recall by Vita Health and will provide updates to Canadians as warranted. Canadians can monitor the chart below for the list of recalled products.

----------------------------------------------------------------------------Product Lots----------------------------------------------------------------------------Life Extra Strength Allergy Sinus 2A118B2M4Y, 2A118B2R10, 2A118B2RKG,Medication 2F177B2YEY, 2F177B32M8----------------------------------------------------------------------------Tanta Extra Strength Allergy Sinus 3A1702YN3, 3A1013293Medication----------------------------------------------------------------------------Exact Extra Strength Allergy Sinus 2A1092L8T, 2D0572PTY, 2D0962QWH,Medication (24 count) 2F1812SXE, 2J2992VLU, 2J3052X7X, 2J3192X7X, 3A0683082, 3A17031AJ----------------------------------------------------------------------------Exact Extra Strength Allergy Sinus 1L1622L8P, 2A1092L8P, 2D0962QWN,Medication (50 count) 2D2652QWN, 2F1812SRV, 2G0012SRV, 2G0012TWJ, 2J2992VLR----------------------------------------------------------------------------Rexall Extra Strength Allergy Sinus 2A1092NAH, 2G0012R3SMedication (24 count)----------------------------------------------------------------------------Rexall Extra Strength Allergy Sinus 2D2652Q29Medication (50 count)----------------------------------------------------------------------------Rexall Extra Strength Allergy Sinus 1H195B2JPT, 1H195B2L6Y, 2A118B2QS8,Medication (12 count) 2A118B2TC1, 2F177B2Z7J----------------------------------------------------------------------------

Photos of the products are available at the following address:

For more information:

Complaints involving labeling errors associated with Vita Health products can be reported to Health Canada by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch InspectorateHealth CanadaAddress Locator: 2003COttawa, Ontario K1A 0K9


Fax: 613-946-5636

How to report side effects to health products 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.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

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Media Inquiries:
Health Canada

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Source: Marketwire

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