Hizentra (2020-01-16)

Starting date:
January 16, 2020
Type of communication:
Drug Recall
Subcategory:
Drugs, Biologic/vaccine
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72153

Last updated:

Summary

  • Product: Hizentra, also known as immune globulin (human) 10 ml single used prefilled syringes

Reason

Atypical appearance (viscous or gelatinous solution) of product in affected lot.

Depth of distribution

End users

Affected products

Hizentra, also known as immune globulin (human) 10 ml single used prefilled syringes

DIN, NPN, DIN-HIM

DIN 02463067

Dosage form

Solution

Strength

Immunoglobulin (Human) 200 mg/mL

Lot or serial number

P100047093

Companies

Recalling Firm
CSL Behring Canada Inc.
Suite 1460, 55 Metcalfe Street,
Ottawa
K1P 6L5
Ontario
CANADA
Marketing Authorization Holder
CSL Behring Canada Inc.
Suite 1460, 55 Metcalfe Street,
Ottawa
K1P 6L5
Ontario
CANADA