Kimmtrak Solution; Out of specification (in-vitro potency assay)
· Published by Health Canada · Official notice
Alert type: Health product recall
Category: Health products - Biologic or vaccine
Product: Kimmtrak Solution
Issue: Health products - Product quality
What to do: Consult your health care professional if you have any health concerns.
Audience: General public, Healthcare, Industry
Recall class: Type II
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| 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 |
The in-vitro potency assay is out of specification in the affected lots.