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Medicines defect noticeMHRA

Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the most up to date safety information.

Check your product

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

17 identifiers listed for this notice.

  • Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets 50

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • A4659
    • A4660
    • N3560
    • A4705
    • M3556
    Product licenceThe PL number on the carton.
    • PL 04569/0779
    • PL 04569/0780
    • PL 04569/0781
    ExpiryOn the carton, blister or label.
    • 03/2026
    • 04/2026
    • 02/2026
    • 12/2025
    First distributedOn the product, its label or its packaging.
    • 29/02/2024
    • Not yet distributed
    • 05/02/2024
    • 18/03/2024
    • 09/02/2024

What to do now

The problem with Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets 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(24)A/22). Quoted as issued.

Summary

Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the most up to date safety information.

The risk

MDR number MDR 043-05/24 Company name

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Due to supply considerations, batch A4660 that has yet to be distributed will not be repackaged with the updated PIL prior to distribution. Viatris UK Healthcare Ltd has confirmed that all future batches of the product will contain the updated PIL.

Healthcare professionals are advised to ensure that patients are aware of the updated safety information when dispensing the affected batches of product. Please provide a copy of the updated PIL and remind the patient to read the entire leaflet before taking the medicine. The electronic versions of the PIL are up to date and can be accessed via the following links:

Oxcarbazepine Mylan 150 mg Film-coated Tablets - Patient Information Leaflet (PIL)

Oxcarbazepine Mylan 300 mg Film-coated Tablets - Patient Information Leaflet (PIL)

Oxcarbazepine Mylan 600 mg Film-coated Tablets - Patient Information Leaflet (PIL)

Hard copies of the updated PIL can also be requested from Viatris UK Healthcare Ltd (see contact details below) so that current stock in the dispensary can be supplemented with the correct PIL.

The medicine itself is not affected and patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients should be aware that the Patient Information Leaflet included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected information is summarised in Appendix 1 of this notification. The up-to-date version of the Patient Information Leaflet can be accessed via the links above. Please read this before taking the medicine.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme .

Advice for patients

The medicine itself is not affected and patients do not need to take any action. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients should be aware that the Patient Information Leaflet included in the packs of the above specified batches of medicines does not contain the most up to date safety information. The affected information is summarised in Appendix 1 of this notification. The up-to-date version of the Patient Information Leaflet can be accessed via the links above. Please read this before taking the medicine.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme .

Open the MHRA notice

Questions

Why has Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets been recalled?

The problem with Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets 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, 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?

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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