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Medicines recallMHRA

Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection recalled over an impurity

Impurity above limitsMedium riskClass 3

Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compound C impurity during stability testing.

Check your product

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

9 identifiers listed for this notice.

  • Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection 1 vial pack

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • P2206998
    • P2300471
    • P2302576
    Product licenceThe PL number on the carton.
    • PLGB 20075/1408
    ExpiryOn the carton, blister or label.
    • 30/11/2025
    • 31/03/2026
    First distributedOn the product, its label or its packaging.
    • 11/08/2023
    • 06/02/2024
    • 05/07/2024

What to do now

Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension has been recalled as a precaution because of an impurity.

  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. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

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/08). Quoted as issued.

Summary

Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification results for Azacitidine related compound C impurity during stability testing.

The risk

DMRC reference number DMRC-34527566 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all stock from these batches and return it to your supplier using your supplier’s approved process.

Accord Healthcare Limited is recalling the above batches as a precautionary measure, no adverse reactions have been reported with these batches to date.

Patients are not required to take any action. This product is administered by healthcare professionals only.

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 are not required to take any action. This product is administered by healthcare professionals only.

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 Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension been recalled?

Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension has been recalled as a precaution because of an impurity. Limits for impurities are set for lifetime exposure, so short-term use is unlikely to cause harm. Recalls of this kind are usually precautionary.

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?

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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