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Medicines recallMHRA

Pedmarqsi 80 mg/mL solution for infusion recalled over possible contamination

Contamination or sterilityHigh riskClass 2

Norgine Pharmaceuticals Limited is recalling the batches listed in the table due to risk of particulate matter being present in the product identified during routine stability investigations.

Check your product

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

5 identifiers listed for this notice.

  • Pedmarqsi 80 mg/mL solution for infusion 1

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 458273
    • 475287
    ExpiryOn the carton, blister or label.
    • 12/2026
    First distributedOn the product, its label or its packaging.
    • 09/01/2025
    • 25/09/2025

What to do now

Pedmarqsi 80 mg/mL solution for infusion has been recalled because the product may not be as clean or sterile as it should be.

  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. 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

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(26)A/42). Quoted as issued.

Summary

Norgine Pharmaceuticals Limited is recalling the batches listed in the table due to risk of particulate matter being present in the product identified during routine stability investigations.

The risk

DMRC reference number DMRC - 41054154 Marketing Authorisation Holder

Advice for healthcare professionals

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

Other batches of this product remain available for continued use. Healthcare professionals are reminded of the Patient Information Leaflet instruction to inspect visually the content of the vial(s) for particulate matter and discoloration prior to administration.

Inline filters may be used with this product.

This is a Pharmacy and Wholesaler level recall, therefore no further action is required by patients. This product is normally administered by healthcare professionals in a hospital setting.

Norgine Pharmaceuticals Limited have not received any reports of adverse reactions related to the issue.

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

This is a Pharmacy and Wholesaler level recall, therefore no further action is required by patients. This product is normally administered by healthcare professionals in a hospital setting.

Norgine Pharmaceuticals Limited have not received any reports of adverse reactions related to the issue.

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 Pedmarqsi 80 mg/mL solution for infusion been recalled?

Pedmarqsi 80 mg/mL solution for infusion has been recalled because the product may not be as clean or sterile as it should be. 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, 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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