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Health product recall

Baxsero (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-53357

Recalled Products

Baxsero

Reason

Products were stored outside of recommended temperatures.

Depth of distribution

Shoppers Drug Mart Pharmacies in Ontario and Quebec

Affected products

Baxsero

DIN, NPN, DIN-HIM
DIN 02417030
Dosage form

Suspension

Strength

Outer membrane vesicles (Neisseria meningitidis group B NZ98/254 strain) 25 µg / 0.5 mL
Recombinant Neisseria meningitidis group B NHBA fusion protein 50 µg / 0.5 mL
Recombinant Neisseria meningitidis group B NadA protein 50 µg / 0.5 mL
Recombinant Neisseria meningitidis group B fHBP fusion protein 50 µg / 0.5 mL

Lot or serial number

132701

Companies
Recalling Firm
Shoppers Drug Mart
243 Consumers Road
Toronto
M2J 4W8
Ontario
CANADA
Marketing Authorization Holder
Novartis Vaccines And Diagnostics, Inc.
350 Massachusetts Ave
Cambridge
02139
Massachusetts
UNITED STATES

Date modified: