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
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), 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.
Additional information
Background
Depth of recall: Distributors
Details
Original published date: 2022-02-23
Alert / recall type
Health product recall
Category
Health product - 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