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:
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
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