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Medicines defect noticeMHRA

Keppra 500mg film-coated tablets defect notice over a packaging defect

Packaging or device defectMedium riskClass 3

The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification. Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V.

Check your product

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

51 identifiers listed for this notice.

  • Keppra 500mg film-coated tablets 60 tablets

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 341173/BA
    • 366686/BA
    • 359701/BA
    • 366621/BA
    • 366635/BA
    • 366635/BB
    • 366101/BA
    • 366635/BC
    • 369420/BA
    • 369421/BA
    • 369421/BB
    • 371089/BA
    • 367482/BA
    • 369420/BB
    • 380087/BA
    • 357677/BA
    • 346651/BA
    • 366635/BD
    • 371089/BB
    • 371016/BA
    • 369420/BC
    • 379799/BA
    • 380087/BB
    • 381719/BA
    • 369421/BC
    • 380089/BB
    • 371016/BB
    • 380089/BA
    Product licenceThe PL number on the carton.
    • PL 56830/0005
    ExpiryOn the carton, blister or label.
    • 07/2024
    • 05/2025
    • 06/2025
    • 07/2025
    • 08/2025
    • 02/2026
    • 01/2025
    • 09/2024
    • 12/2025
    First distributedOn the product, its label or its packaging.
    • 21/08/2023
    • 21/09/2023
    • 06/11/2023
    • 01/12/2023
    • 25/01/2024
    • 01/02/2024
    • 05/02/2024
    • 12/03/2024
    • 02/04/2024
    • 08/04/2024
    • 11/04/2024
    • 23/04/2024
    • 24/04/2024

What to do now

Some packs of Keppra 500mg film-coated tablets have a defect that could affect how the medicine is given.

  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

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/15). Quoted as issued.

Summary

The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification. Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by BModesto B.V.

The risk

MDR number MDR 082-05/24 Company name

Advice for healthcare professionals

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

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Specific batches of Keppra 500mg film-coated tablets have an incorrect strength printed in Braille on the outer pack, it reads 1000mg instead of 500mg. The pack contains 500mg tablets as prescribed and quality of the medicine itself is not affected by this defect. Patients are reminded to take the tablets as per the instructions from your healthcare professional and those found on the dispensing label. If there are any concerns, consult with your healthcare professional. Never stop taking medicines such as Keppra without medical advice. Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before.

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

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Specific batches of Keppra 500mg film-coated tablets have an incorrect strength printed in Braille on the outer pack, it reads 1000mg instead of 500mg. The pack contains 500mg tablets as prescribed and quality of the medicine itself is not affected by this defect. Patients are reminded to take the tablets as per the instructions from your healthcare professional and those found on the dispensing label. If there are any concerns, consult with your healthcare professional. Never stop taking medicines such as Keppra without medical advice. Suddenly stopping an epilepsy medicine may cause your seizures to start again or happen more often or last longer than before.

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 Keppra 500mg film-coated tablets been recalled?

Some packs of Keppra 500mg film-coated tablets 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?

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?

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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