Canadian Recall: Allergy Sinus Medications recalled due to a labeling 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.
  • 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


Public inquiries

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