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Medicines recallMHRA

Adakveo 10 mg/ml concentrate for solution for infusion recalled over a quality concern

Medicine quality concernHigh riskClass 2

Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.

Check your product

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

4 identifiers listed for this notice.

  • Adakveo 10 mg/ml concentrate for solution for infusion 1 vial

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • SJFN5
    Product licenceThe PL number on the carton.
    • PLGB 00101/1191
    ExpiryOn the carton, blister or label.
    • 30/09/2024
    First distributedOn the product, its label or its packaging.
    • 23/05/2023

What to do now

The MHRA has issued a notice about Adakveo 10 mg/ml concentrate for solution for infusion.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

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

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.

Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/06). Quoted as issued.

Summary

Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA.

The risk

MDR number MDR 183-01/24 Company name

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and await contact from the Novartis Pharmaceuticals UK Limited customer care team who will contact healthcare professionals directly to arrange return. Novartis Pharmaceuticals UK Limited have a direct to pharmacy supply chain agreement based on the specialist use of the product and know the exact hospitals who have been supplied with the impacted batch.

Clinicians and prescribers who initiated patients on Adakveo 10 mg/ml concentrate for solution for infusion should inform patients of the licence revocation and discuss alternative treatment options with them. No new patients should be started on Adakveo in the UK.

Healthcare professionals who receive any questions from patients related to the recall notice should advise patients undergoing treatment to discuss any questions or concerns with their prescribing healthcare professional. No new patients should be started on Adakveo in the UK.

A Dear Healthcare Professional Letter (DHPC) was sent on 10 January 2024 announcing the revocation of Adakveo by Novartis Pharmaceuticals UK Limited.

See full text link for the DHPC: https://www.medicines.org.uk/emc/dhpc/2874/Document

Patients currently prescribed Adakveo 10 mg/ml concentrate for solution for infusion will be contacted by their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options. Do not stop administering Adakveo without talking to your prescribing 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 currently prescribed Adakveo 10 mg/ml concentrate for solution for infusion will be contacted by their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options. Do not stop administering Adakveo without talking to your prescribing 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 Adakveo 10 mg/ml concentrate for solution for infusion been recalled?

The MHRA has issued a notice about Adakveo 10 mg/ml concentrate for solution for infusion. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

How do I know if my medicine is affected?

Compare the batch code, product licence, 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?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

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