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Health product recall

Rexall Extra Strength Allergy Sinus Medication

Starting date:
August 16, 2013
Posting date:
September 10, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-35331

Recalled Products

Rexall Extra Strength Allergy Sinus Medication

Reason

The inner printing on the outer carton of the product is missing the contraindication for “chronic lung disease”.  The product contains active ingredients acetaminophen, pseudoephedrine HCl, and chlorpheniramine maleate.  The chronic lung disease warning is required for products containing chlorpheniramine maleate because it is an antihistamine that is thought to produce anticholinergic effects including dryness of the mouth and respiratory passages.

Depth of distribution

Distributed to the retail level.  Nationally in Canada only.

Affected products

Rexall Extra Strength Allergy Sinus Medication

DIN, NPN, DIN-HIM
DIN 02159546
Dosage form

Tablet

Strength
Pseudoephedrine Hydrochloride
30 mg
Acetaminophen
500 mg
Chlorpheniramine Maleate
2 mg
Lot or serial number

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
Companies
Recalling Firm
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA
Marketing Authorization Holder
Vita Health Products Inc.
150 Beghin Ave.
Winnipeg
R2J 3W2
Manitoba
CANADA