RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27
Read and act on the official notice on GOV.UK
Class 4 recall — Caution in use.
The MHRA uses Class 4 when:
Usually minor defects in packaging or other printed materials.
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 | 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 this recall | 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
Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.
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 |
|---|---|---|---|
| Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe | |||
| 184472 | 30/11/2028 | 1 pre-filled syringe | 21/01/2026 |
| 186711 | 30/11/2028 | 1 pre-filled syringe | 21/04/2026 |
| 188656 | 28/02/2029 | 1 pre-filled syringe | 01/06/2026 |
MHRA's audience tags: Dispensing GP practices, General practice, Pharmacy