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Health product recall

Sanofi Pasteur Product Recall (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-53359

Recalled Products

A. Adacel

B. Avaxim

C. Avaxim - Pediatric (Syringe)

D. Typhim VI

E. Vaxigrip

F. Vivaxim

G. Menactra

Reason

Products were stored outside of recommended temperatures.

Depth of distribution

Shoppers Drug Mart Pharmacies in Ontario and Quebec

Affected products

A. Adacel

DIN, NPN, DIN-HIM
DIN 02240255
Dosage form

Suspension

Strength

Diphtheria Toxoid 2 LF / 0.5 mL
Filamentous Haemagglutinin 5 µg / 0.5 mL
Fimbriae Types 2 and 3 (FIM) 5 µg / 0.5 mL
Pertactin 3 µg / 0.5 mL
Pertussis Toxoid 2.5 µg / 0.5 mL
Tetanus Toxoid 5 LF / 0.5 mL

Lot or serial number

C4615AC

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Sanofi Pasteur Ltd.
1755 Steeles Ave. West
Toronto
M2R 3T4
Ontario
CANADA

B. Avaxim

DIN, NPN, DIN-HIM
DIN 02237792
Dosage form

Suspension

Strength

Hepatitis A Vaccine, Inactivated 160 unit / 0.5 mL

Lot or serial number

K0034-1

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Sanofi Pasteur Ltd.
1755 Steeles Ave. West
Toronto
M2R 3T4
Ontario
CANADA

C. Avaxim - Pediatric (Syringe)

DIN, NPN, DIN-HIM
DIN 02243741
Dosage form

Suspension

Strength

Hepatitis A Vaccine, Inactivated 80 unit / 0.5 mL

Lot or serial number

J0278-1

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Sanofi Pasteur Ltd.
1755 Steeles Ave. West
Toronto
M2R 3T4
Ontario
CANADA

D. Typhim VI

DIN, NPN, DIN-HIM
DIN 02130955
Dosage form

Solution

Strength

Salmonella Typhi VI Capsular Polysaccharide Vaccine 25 µg / 0.5 mL

Lot or serial number

L0069-1

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Sanofi Pasteur Ltd.
1755 Steeles Ave. West
Toronto
M2R 3T4
Ontario
CANADA

E. Vaxigrip

DIN, NPN, DIN-HIM
DIN 02367718
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 15 µg / 0.5 mL

Lot or serial number

L0173-1

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Sanofi Pasteur Ltd.
1755 Steeles Ave. West
Toronto
M2R 3T4
Ontario
CANADA

F. Vivaxim

DIN, NPN, DIN-HIM
DIN 02248361
Dosage form

Solution, Suspension

Strength

Hepatitis A Vaccine, Inactivated 160 unit / 0.5 mL
Salmonella Typhi VI Capsular Polysaccharide Vaccine 25 µg / 0.5 mL

Lot or serial number

K5139-1

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Sanofi Pasteur Ltd.
1755 Steeles Ave. West
Toronto
M2R 3T4
Ontario
CANADA

G. Menactra

DIN, NPN, DIN-HIM
DIN 02279924
Dosage form

Solution

Strength

Meningococcal Polysaccharide - Diptheria Toxoid Conjugate, Group A 4.0 µg / 0.5 mL
Meningococcal Polysaccharide - Diptheria Toxoid Conjugate, Group C 4.0 µg / 0.5 mL
Meningococcal Polysaccharide - Diptheria Toxoid Conjugate, Group W 135 4.0 µg / 0.5 mL
Meningococcal Polysaccharide - Diptheria Toxoid Conjugate, Group Y 4.0 µg / 0.5 mL

Lot or serial number

U4835AE

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Sanofi Pasteur Ltd.
1755 Steeles Ave. West
Toronto
M2R 3T4
Ontario
CANADA