RecallClass 2 · Action within 48 hours
Class 2 Medicines Recall: Norgine Pharmaceuticals Limited, Pedmarqsi 80 mg/mL solution for infusion, EL(26)A/42
Read and act on the official notice on GOV.UK
Class 2 recall — Action within 48 hours.
The MHRA uses Class 2 when:
The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 this recall | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
The MHRA's summary
Norgine Pharmaceuticals Limited is recalling the batches listed in the table due to risk of particulate matter being present in the product identified during routine stability investigations.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| Pedmarqsi 80 mg/mL solution for infusion | |||
| 458273 | 12/2026 | 1 | 09/01/2025 |
| 475287 | 12/2026 | 1 | 25/09/2025 |
MHRA's audience tags: Dispensing GP practices, Pharmacy