Kimmtrak Solution; Out of specification (in-vitro potency assay)
Brand(s)
Last updated
Summary
Product
Kimmtrak Solution
Issue
Health products - Product quality
What to do
Consult your health care professional if you have any health concerns.
Affected products
| Brand | Product Name | Market Authorization | Dosage Form | Strength | Lot number |
|---|---|---|---|---|---|
| Immunocore | Kimmtrak Solution | DIN 02527588 | Solution | Tebentafusp 100 mcg/0.5 mL | 3D009AA06, 3D009AA20, 3D009AA38 |
Issue
The in-vitro potency assay is out of specification in the affected lots.
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: Wholesalers, Health Care Establishments
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Biologic or vaccine
Companies
Recalling Firm
Medison Pharma Canada Inc.
Suite 400- 154 University Avenue.
Toronto, ON M5H 3Y9
Marketing Authorization Holder
Immunocore Ireland Limited
1 Sky Business Centres; Unit 21 Block Port Tunnel; Business Park, Clonshaugh
Dublin IRLANDE 17
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77610
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