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Medicines recallMHRA

Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag recalled over possible contamination

Contamination or sterilityHigh riskClass 2

Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during stability testing.

Check your product

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

8 identifiers listed for this notice.

  • Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag 1

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • HAF1473A
    • HAF0544A
    Product licenceThe PL number on the carton.
    • PL 31750/0193
    • PL 31750/0190
    ExpiryOn the carton, blister or label.
    • 31/05/2026
    • 28/02/2026
    First distributedOn the product, its label or its packaging.
    • 02/10/2024
    • 20/05/2024

What to do now

Affected batches of Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag may be contaminated, for example with particles or microorganisms.

  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. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

Symptoms and when to get help

Look out for

  • redness, swelling or pain where the product was used
  • a high temperature

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(25)A/09). Quoted as issued.

Summary

Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during stability testing.

The risk

DMRC reference number DMRC-34805959 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process. This medicine is being recalled as a precautionary measure and should present no direct harm to patients who have already received these batches.

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients do not have direct contact with this type of medicine as it must be administered by a 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

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Patients do not have direct contact with this type of medicine as it must be administered by a 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 Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag been recalled?

Affected batches of Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/100ML (8mg/ml) Infusion bag may be contaminated, for example with particles or microorganisms. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.

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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