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Medicines recallMHRA

Class 4 Medicines Notification, Accord Healthcare Limited recalled over a packaging defect

Packaging or device defect

Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.

Check your product

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

35 identifiers listed for this notice.

  • Product 1 2ML

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • M2212320
    • M2212979
    ExpiryOn the carton, blister or label.
    • 06/2025
    • 08/2025
    First distributedOn the product, its label or its packaging.
    • 21-04-2023
    • 18-01-2023

  • Product 2 5ML

    Batch code
    • M2212561
    • M2216090
    Expiry
    • 07/2025
    • 10/2025
    First distributed
    • 28-11-2022
    • 18-04-2023

  • Product 3 15ML

    Batch code
    • G2300725
    Expiry
    • 11/2025
    First distributed
    • 08-06-2023

  • Product 4 25ML

    Batch code
    • M2210458
    • M2211881
    • G2300727
    • M2301081
    Expiry
    • 02/2025
    • 07/2025
    • 09/2025
    • 11/2025
    First distributed
    • 30-11-2022
    • 06-01-2023
    • 16-06-2023
    • 02-06-2023

  • Product 5 50ML

    Batch code
    • G2202180
    • G2300728
    • M2211019
    Expiry
    • 05/2024
    • 07/2025
    First distributed
    • 18-01-2023
    • 10-07-2023
    • 13-10-2022

What to do now

The problem with Class 4 Medicines Notification, Accord Healthcare Limited is the pack or device, such as a syringe, cap, blister or inhaler.

  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. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(23)A/30). Quoted as issued.

Summary

Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these products mentioned in this notification.

The risk

MDR number MDR 105-08/23 Company name

Advice for healthcare professionals

There is no risk to product quality as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the product and where possible, provide an updated PIL. The updated PIL is available electronically and can be downloaded from the Accord website.

Healthcare professionals are advised to exercise caution when prescribing this product to UGT1A1 poor metabolisers, such as patients with Gilbert’s syndrome, due to an increased risk of severe adverse reactions. Consult the Summary of Product Characteristics for further advice.

This issue is about missing information on the Patient Information Leaflets (PILs). The medicine itself is not affected and therefore patients do not need to take any action.

Talk to your doctor, pharmacist or nurse before using Irinotecan Hydrochloride if you have Gilbert’s syndrome, an inherited condition that can cause elevated bilirubin levels and jaundice (yellow skin and eyes). Your cancer team can provide more information.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. If you have any concerns, please speak with your cancer team or your healthcare professional in the first instance.

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 issue is about missing information on the Patient Information Leaflets (PILs). The medicine itself is not affected and therefore patients do not need to take any action.

Talk to your doctor, pharmacist or nurse before using Irinotecan Hydrochloride if you have Gilbert’s syndrome, an inherited condition that can cause elevated bilirubin levels and jaundice (yellow skin and eyes). Your cancer team can provide more information.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care. If you have any concerns, please speak with your cancer team or your healthcare professional in the first instance.

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 Class 4 Medicines Notification, Accord Healthcare Limited been recalled?

The problem with Class 4 Medicines Notification, Accord Healthcare Limited is the pack or device, such as a syringe, cap, blister or inhaler. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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?

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?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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