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Health product recall

Paclitaxel for injection (2013-09-19)

Starting date:
March 19, 2013
Posting date:
October 18, 2013
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-36023

Recalled Products

Paclitaxel for injection 

Reason

During ongoing shelf life studies, a degradant was above the test limit.

Depth of distribution

Wholesaler

Affected products

Paclitaxel for injection

DIN, NPN, DIN-HIM
DIN 02320010
Dosage form

Solution for injection

Strength
  • 30 mg (5 mL) 
  • 100 mg  (16,7 mL)
  • 150 mg  (25 mL)
  • 300 mg (50 mL)
Lot or serial number

Product Code / Batch Numbers

  • ST-AB111 (5mL)
  • AB111B11
  • ST-AB121 (16.7 mL) 
  • AB121A11
  • W562
  • W847
  • Y157
  • ST-AB131 (25 mL) 
  • W563
  • ST-AB141 (50 mL)
  • AB141A11
  • W564
Companies
Recalling Firm
Sterimax Inc.
1 - 2735 Matheson Blvd. East
Mississauga
L4W 4M8
Ontario
CANADA
Marketing Authorization Holder
Sterimax Inc.
1 - 2735 Matheson Blvd. East
Mississauga
L4W 4M8
Ontario
CANADA

Date modified: