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Medicines defect noticeMHRA

Entyvio 108mg solution for injection in pre-filled syringe defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet for specified batches of Entyvio 108mg pre-filled syringes.

Check your product

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

10 identifiers listed for this notice.

  • Entyvio 108mg solution for injection in pre-filled syringe Pack containing 2 pre-filled syringes

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 12741441
    • 12788930
    • 12816782
    Product licenceThe PL number on the carton.
    • PLGB 15475/0073
    ExpiryOn the carton, blister or label.
    • 12/2025
    • 02/2026
    • 06/2026
    First distributedOn the product, its label or its packaging.
    • 06/06/2024
    • 29/08/2024
    • 15/11/2024

What to do now

Some packs of Entyvio 108mg solution for injection in pre-filled syringe have a defect that could affect how the medicine is given.

  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. 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

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(24)A/55). Quoted as issued.

Summary

Takeda UK Limited has informed the MHRA that there is an error in the Patient Information Leaflet for specified batches of Entyvio 108mg pre-filled syringes.

The risk

DMRC reference number DMRC-33832314 Company name

Advice for healthcare professionals

Healthcare professionals should advise the patient of the possibility of these adverse reactions and refer patients to the electronic version of the Patient Information Leaflet ( PIL ) .

Patients should also be told that there is no patient alert card with this medicine.

Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

The online version of the Patient Information Leaflet ( PIL ) is correct.

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 should continue to take medicines from these batches as prescribed by your healthcare professional.

The online version of the Patient Information Leaflet ( PIL ) is correct.

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 Entyvio 108mg solution for injection in pre-filled syringe been recalled?

Some packs of Entyvio 108mg solution for injection in pre-filled syringe have a defect that could affect how the medicine is given. 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, 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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