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Medicines recallMHRA

Evorel Sequi recalled over a packaging defect

Packaging or device defectMedium riskClass 3

Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 and Evorel Conti patches.

Check your product

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

4 identifiers listed for this notice.

  • Evorel Sequi 8 patches

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 6029403
    Product licenceThe PL number on the carton.
    • PL 49105/0010
    ExpiryOn the carton, blister or label.
    • July 2024
    First distributedOn the product, its label or its packaging.
    • 13th June 2023

What to do now

Some packs of Evorel Sequi 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(23)A/34). Quoted as issued.

Summary

Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 and Evorel Conti patches.

The risk

MDR number MDR 240-08/23 Company name

Advice for healthcare professionals

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

If a patient presents with the incorrect patches, they should be dispensed a correct pack from another batch. Theramex has confirmed that all other batches are unaffected and that there is no impact on supply.

For prescriptions written within the last 6 months, check the pack being returned by the patient and the dispensing record (Summary Care Record may be checked with the patient’s consent). Following advice from the Department of Health and Social Care, this is considered a correction to the original prescription and a further prescription would not be necessary. Follow your company’s returns procedure through your wholesaler to arrange a credit note or contact Theramex (see Further information below for contact details).

Patients who may have received the impacted batch of Evorel Sequi should consider the following information:

Check the contents of your pack to ensure that it contains four (4) Evorel 50 patches and four (4) Evorel Conti patches. The packaging is clearly labelled with the medication names.

If you have received four (4) of each patch, please continue to take the medicine as prescribed by your healthcare professional. You do not need to take any action.

If you do not have 4 of each patch, please contact your pharmacist. If the prescription was written within the past 6 months, the pharmacist will arrange for the dispensing of a correct pack from another batch. Alternatively, contact your GP directly as a new prescription may be required.

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 who may have received the impacted batch of Evorel Sequi should consider the following information:

Check the contents of your pack to ensure that it contains four (4) Evorel 50 patches and four (4) Evorel Conti patches. The packaging is clearly labelled with the medication names.

If you have received four (4) of each patch, please continue to take the medicine as prescribed by your healthcare professional. You do not need to take any action.

If you do not have 4 of each patch, please contact your pharmacist. If the prescription was written within the past 6 months, the pharmacist will arrange for the dispensing of a correct pack from another batch. Alternatively, contact your GP directly as a new prescription may be required.

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 Evorel Sequi been recalled?

Some packs of Evorel Sequi 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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