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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