Health product recall

Octagam 10% (Immune globulin intravenous, Human):Quality issue

Last updated

Summary

Product
Octagam 10% (Immune globulin intravenous, Human)
Issue
Health products - Product quality
What to do

See instructions below. 

Affected products

Brand Product Name Market Authorization Dosage Form Strength Lot
Octagam 10% (Immune globulin intravenous, Human) Octagam 10% (Immune globulin intravenous, Human) DIN 02380145 Solution Immunoglobulin (Human) 100mg/ml K130A8562

Issue

Elevated reporting rate of hypersensitivity reactions in affected lot. 

What you should do

  1. Verify if your product is affected.
  2. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  3. Contact the recalling firm if you have any questions about the recall.
  4. Report any health product related side effects to Health Canada.
  5. Report any other health product safety complaints to Health Canada.

Additional information

Background

Depth of recall: Distributors

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

Octapharma Canada Inc.

308-214 King Street West,

Toronto, Ontario

M5H 3S6

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63944