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Health product recall

Extra Strength Cold & Flu-In-One

Starting date:
July 22, 2013
Posting date:
July 23, 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-34733

Recalled products

  1. Extra Strength Cold & Flu-In-One

Reason

The caution statement:

"CAUTION: KEEP OUT OF THE REACH OF CHILDREN. This package contains enough drug to seriously harm a child."

This statement is missing in both French and English. As this is a blister pack there is no child resistant packaging for this product.

Affected products

A. Extra Strength Cold & Flu-In-One

DIN, NPN, DIN-HIM
DIN 02368528
Dosage form
  • Caplet
Strength
Medicinal Ingredient Strength for Daytime and Nighttime Extra Strength Cold & Flu-In-One
Medicinal Ingredient Daytime Nighttime
Dextromethorphan Hydrobromide 15 mg Not applicable
Psudoephedrine Hydrochloride 30 mg 30 mg
Guaifenesin 100 mg Not applicable
Acetaminophen 500 mg 500 mg
Diphenhydramine Hydrochloride Not applicable 25 mg
Lot or serial number
  • 00056682
  • 00062907
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

Date modified: