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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