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Medicines recallMHRA

Kimmtrak 200 micrograms/mL concentrate for solution recalled over a strength or dose problem

Wrong strength or doseMedium riskClass 3

Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.

Check your product

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

11 identifiers listed for this notice.

  • Kimmtrak 200 micrograms/mL concentrate for solution for infusion, Immunocore Limited 1 vial

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 3D009AA17
    • 3D009AA19
    • 3D009AA36
    • 3D009AA39*
    • 3D009AA04*
    ExpiryOn the carton, blister or label.
    • 31/03/2026
    First distributedOn the product, its label or its packaging.
    • 08/2024
    • 10/2024
    • 12/2024
    • 01/2025
    • 09/2024

What to do now

Kimmtrak 200 micrograms/mL concentrate for solution for infusion has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves.

  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 medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.

An affected pack bought over the counter can be returned to where you bought it.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(25)A/28). Quoted as issued.

Summary

Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.

The risk

DMRC reference number DMRC-35860567 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the impacted batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process. The batches listed in the table are being recalled as a precautionary measure.

Patients who are taking Kimmtrak 200 micrograms/mL concentrate for solution for infusion (tebentafusp) should continue to take the medication. This is a wholesale and pharmacy level recall that will be actioned by your healthcare professional.

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

Advice for patients

Patients who are taking Kimmtrak 200 micrograms/mL concentrate for solution for infusion (tebentafusp) should continue to take the medication. This is a wholesale and pharmacy level recall that will be actioned by your healthcare professional.

Patients who experience adverse reactions or have any questions about the 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 Kimmtrak 200 micrograms/mL concentrate for solution for infusion been recalled?

Kimmtrak 200 micrograms/mL concentrate for solution for infusion has been recalled because test results for the affected batches were outside the approved limits for strength or how the medicine dissolves. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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?

The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.

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