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Prolia (denosumab) (2013-09-24)

Starting date:
September 24, 2013
Posting date:
October 18, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-36025

Recalled Products

Prolia (denosumab) 

Reason

One lot of Prolia, lot 1035671 (packaged from Prolia batch 0010136386) is subject to a recall, after identifying the presence of particulate (cellulose) matter in a small number of pre-filled syringes.

Depth of distribution

Wholesalers in all provinces in Canada.

Affected products

Prolia (denosumab) 

DIN, NPN, DIN-HIM
DIN 02343541
Dosage form

Solution for injection

Strength
  • 60 mg/mL (single-use prefilled syringe)
Lot or serial number

Lot # 1035671*

  • *lot packaged from Prolia batch 0010136386
Companies
Recalling Firm
Amgen Canada Inc.
100 - 6775 Financial Drive
Mississauga
L5N 0A4
Ontario
CANADA
Marketing Authorization Holder
Amgen Canada Inc.
100 - 6775 Financial Drive
Mississauga
L5N 0A4
Ontario
CANADA