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

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