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Health product recall

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 02380145

Dosage 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