PV Bulletin
Medicines and Healthcare products Regulatory Agency (MHRA)United Kingdom

Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe

MHRA issued a Class 4 defect notification for Ponlimsi (Denosumab) 60mg solution for injection, requiring healthcare professionals to check stock for affected batches.

Primary source: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-teva-uk-ltd-ponlimsi-denosumab-60mg-solution-for-injection-in-pre-filled-syringe-el-26-a-slash-27

PV Impact Brief

MonitoringConfidence: high

What changed

MHRA issued a Class 4 medicines defect notification for Ponlimsi (Denosumab) 60mg solution for injection (Teva UK Ltd).

Why it matters

Class 4 defect notifications indicate a potential quality issue that does not pose a serious risk to patient safety but requires action to ensure product integrity and correct usage.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Action needed

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

Owner

Regulatory Intelligence Lead

Review cadence

Immediate review and action; monitor for updates from MHRA.

Regulatory action details

Action type
Medicines recall/notification
Publication date
2026-06-04
Safety issue
Labelling error on the carton (states 'For application to the skin' instead of 'subcutaneous use'). The product itself is correct and intended for subcutaneous injection.

Affected products

  • Ponlimsi (Denosumab) 60mg Solution for Injection
    Teva UK Ltd
    184472186711188656

PV internal implications

HCPs should note the labeling error. Ensure correct administration (subcutaneous). Report any adverse reactions via Yellow Card.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 4, 2026

Full briefing

Practical implication

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

The MHRA published a Class 4 medicines defect notification for Teva UK Ltd's Ponlimsi (Denosumab) 60mg solution for injection in pre-filled syringes. Healthcare professionals should check their stock for affected batches and follow instructions in the notice.

What changed: MHRA issued a Class 4 medicines defect notification for Ponlimsi (Denosumab) 60mg solution for injection (Teva UK Ltd).

Why it matters: Class 4 defect notifications indicate a potential quality issue that does not pose a serious risk to patient safety but requires action to ensure product integrity and correct usage.

Practical implication: Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#Class 4 Medicines Defect Notification#MHRA#other#firecrawl-agent#regulatory-extraction

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