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Octagam (2017-01-16)
- Starting date:
- January 16, 2017
- Posting date:
- January 25, 2017
- 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-61894
Reason
Elevated reporting rate of hypersensitivity reactions in affected lot.
Depth of distribution
Canadian Blood Services in Ontario, then further distributed to 43 hospitals
Affected products
Octagam
DIN, NPN, DIN-HIM
DIN 02380145Dosage form
Solution for infusion
Strength
10% immunoglobulin G
Lot or serial number
K605A8541
Companies
- Recalling Firm
-
Octapharma Canada Inc.
308 - 214 King Street West
Toronto
M5H 3S6
Ontario
CANADA
- Marketing Authorization Holder
- Not Applicable