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Allergy Sinus Medications recalled due to a labelling error
- Starting date:
- August 30, 2013
- Posting date:
- August 30, 2013
- Type of communication:
- Information Update
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Labelling and Packaging
- Audience:
- General Public
- Identification number:
- RA-35413
Issue
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 labelling 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 Medication | 2A118B2M4Y, 2A118B2R10, 2A118B2RKG, 2F177B2YEY, 2F177B32M8 |
| Tanta Extra Strength Allergy Sinus Medication | 3A1702YN3, 3A1013293 |
| Exact Extra Strength Allergy Sinus Medication (24 count) | 2A1092L8T, 2D0572PTY, 2D0962QWH, 2F1812SXE, 2J2992VLU, 2J3052X7X, 2J3192X7X, 3A0683082, 3A17031AJ |
| Exact Extra Strength Allergy Sinus Medication (50 count) | 1L1622L8P, 2A1092L8P, 2D0962QWN, 2D2652QWN, 2F1812SRV, 2G0012SRV, 2G0012TWJ, 2J2992VLR |
| Rexall Extra Strength Allergy Sinus Medication (24 count) | 2A1092NAH, 2G0012R3S |
| Rexall Extra Strength Allergy Sinus Medication (50 count) | 2D2652Q29 |
| Rexall Extra Strength Allergy Sinus Medication (12 count) | 1H195B2JPT, 1H195B2L6Y, 2A118B2QS8, 2A118B2TC1, 2F177B2Z7J |
Report health or safety concerns
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 Inspectorate
Health Canada
Address Locator: 2003C
Ottawa, Ontario K1A 0K9
E-mail: DCVIU_UVECM@hc-sc.gc.ca
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.
Media enquiries
Health Canada
(613) 957-2983
Public enquiries
613-957-2991
1-866-225-0709
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