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Taxotere (August 02, 2006)

Report a Concern
Starting date:
August 02, 2006
Posting date:
October 30, 2006
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-2006A202

Reason

Complaints received from Finland and Sweden of an overfill in small number of Taxotere solvent vials batch D5F980 used in Taxotere 20 mg batch D5G549. The overfill is approximately 60 % above nominal fill (3,3 mL versus 2,0 mL), which could lead to a decreased in the administrated dose.

Depth of distribution

Wholesalers and Hospitals in Canada only. No exportation.

Affected products

Taxotere

DIN, NPN, DIN-HIM

DIN 02177099

Dosage form

Liquid

Strength

  • 20 mg

Lot or serial number

Solvent batch D5F980 present in combination with concentrate in packaging batch D5G584.

Companies

Recalling Firm
Sanofi-Aventis Canada Inc.
2150 St-Elzéar Blvd. West
Laval Quebec
Canada H7L 4A8
Marketing Authorization Holder
Sanofi-Aventis Canada Inc.
2150 St-Elzéar Blvd. West
Laval Quebec
Canada H7L 4A8