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
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.
In plain English, for the pharmacy team
Why is this relevant to community pharmacy
Pedmarqsi 80 mg/mL solution for infusion is a hospital medicine made by Norgine Pharmaceuticals Limited. This Class 2 medicines recall is for the batches listed in the notice because of a risk that particles may be in the product. It matters to pharmacy teams because the product may be in stock or supplied through the pharmacy supply chain.
What to tell patients
Use your professional judgement for each patient.
- This product is usually given by healthcare professionals in a hospital setting.
- No further action is needed for patients.
- If you have any questions about the medicine, or if you have had an adverse reaction, seek medical attention.
- Any suspected adverse reactions should be reported through the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme.
What needs to be done
- Stop supplying the batches listed in the notice straight away.
- Quarantine any remaining stock of those batches.
- Return the quarantined stock to your supplier using your supplier’s approved process.
- Pharmacists: note that other batches of this product remain available for use.
- Pharmacists: if the product is supplied or handled, remind relevant healthcare staff that the vial should be checked visually for particles and discoloration before it is given.
- Pharmacists: note that inline filters may be used with this product.
- Read and act on the official GOV.UK notice.
Pharmshark summary, checked and approved by Chris Dotchin on 1 Nov 2026. It is not the official notice: always read and act on the GOV.UK notice.
How this summary was written
An AI tool drafted it from the MHRA's own notice and nothing else. A second check compared every line with the notice. Pharmshark's clinical lead then read it against the notice, edited it where needed and approved it. If the MHRA changes the notice, this summary is taken down until it has been checked again.
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