CanadaHIZENTRA (Subcutaneous Immunoglobulin [Human] 20% solution for injection, DIN 02463067; lot P100834477) is affected and can be identified by the brand, dosage/strength and the listed lot number. It was recalled because the appearance is out of specification in the affected lot. Verify if your product is the affected lot, consult your healthcare provider before discontinuing use, contact CSL Behring Canada with questions, and report any side effects or other safety complaints to Health Canada.
What's being recalled
Depth of recall: End users
Companies: CSL Behring Canada, Inc., 55 Metcalfe Street, Suite 350,, Ottawa, ON, K1P 6L5.
How to identify it
Brand: Hizentra; Product Name: Hizentra; Market Authorization: DIN 02463067; Dosage Form: Solution; Strength: Subcutaneous Immunoglobulin (Human) 20% Solution for injection (2g/10mL); Lot: P100834477
The hazard
The appearance is out of specification in the affected lot.
What to do
Verify if your product is affected.
Consult your healthcare provider prior to discontinuing use of the affected product, or for any health concerns.
Contact the recalling firm if you have any questions about the recall.
Report any health product related side effects to Health Canada.
Report any other health product safety complaints to Health Canada.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)