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Health product recall

Fluzone Quadrivalent (2015-04-16)

Starting date:
April 16, 2015
Posting date:
May 12, 2015
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53361

Recalled Products

Fluzone Quadrivalent

Reason

Products were stored outside of recommended temperatures.

Depth of distribution

Shoppers Drug Mart Pharmacies in Ontario and Quebec

Affected products

Fluzone Quadrivalent

DIN, NPN, DIN-HIM

DIN 02420643

Dosage form

Suspension

Strength

Haemagglutinin-Strain A (H1N1) 15 µg / 0.5 mL

Haemagglutinin-Strain A (H3N2) 15 µg / 0.5 mL

Haemagglutinin-Strain B (Victoria) 15 µg / 0.5 mL

Haemagglutinin-Strain B (Yamagata) 15 µg / 0.5 mL

Lot or serial number

UI200AA

Companies
Recalling Firm

Shoppers Drug Mart

243 Consumers Road

Toronto

M2J 4W8

Ontario

CANADA

Marketing Authorization Holder

Sanofi Pasteur Inc.

Discovery Drive

Swiftwater

18370-0187

Pennsylvania

UNITED STATES