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Medicines defect noticeMHRA

Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe defect notice over a packaging defect

Packaging or device defectLow riskClass 4

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.

Check your product

Only products that match these details are covered. Have your pack in front of you.

8 identifiers listed for this notice.

  • Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe 1 pre-filled syringe

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 184472
    • 186711
    • 188656
    ExpiryOn the carton, blister or label.
    • 30/11/2028
    • 28/02/2029
    First distributedOn the product, its label or its packaging.
    • 21/01/2026
    • 21/04/2026
    • 01/06/2026

What to do now

The problem with Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe is the pack or device, such as a syringe, cap, blister or inhaler.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/27). Quoted as issued.

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.

The risk

DMRC reference number DMRC - 39320587 Marketing Authorisation Holder

Advice for healthcare professionals

There is no risk to product quality as a result of this labelling error. Aside from the labelling error, no additional errors have been identified with the product or delivery device, therefore the affected batches are not being recalled.

Healthcare professionals are advised to reassure patients, if contacted, that the product is for subcutaneous injection as described in the Patient Information Leaflet, which contain clear instructions for intended use.

The Summary of Product Characteristics and Patient Information Leaflet can be accessed at the following website https://products.tevauk.com/hcp/denosumab-823?productId=27077

Patients should continue to use syringes from these batches as prescribed by your healthcare professional. This does not affect the quality of the medicine. The cartons contain a syringe for subcutaneous injection as prescribed, and this is a labelling error.

If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients

Patients should continue to use syringes from these batches as prescribed by your healthcare professional. This does not affect the quality of the medicine. The cartons contain a syringe for subcutaneous injection as prescribed, and this is a labelling error.

If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Open the MHRA notice

Questions

Why has Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe been recalled?

The problem with Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe is the pack or device, such as a syringe, cap, blister or inhaler. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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