MHRA Class 3 Medicines Recall: Keppra 500mg film-coated tablets (Doncaster Pharma Limited)

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.

Class 3 Medicines Recall: Keppra 500mg film-coated tablets (Doncaster Pharma Limited)

Drug alert number: EL (24)A/15

Date issued: 22 May 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Keppra 500mg film-coated tablets (Doncaster Pharma Limited)

Company name: Doncaster Pharma Limited

Product name: Keppra 500mg film-coated tablets, PL 56830/0005

SNOMED Code: N/A

Batch Number Expiry date Pack size First distributed
341173/BA 07/2024 60 tablets 21/08/2023
366686/BA 05/2025 60 tablets 21/08/2023
359701/BA 06/2025 60 tablets 21/08/2023
366621/BA 07/2025 60 tablets 21/08/2023
366635/BA 07/2025 60 tablets 21/09/2023
366635/BB 07/2025 60 tablets 21/09/2023
366101/BA 07/2025 60 tablets 06/11/2023
366635/BC 07/2025 60 tablets 06/11/2023
369420/BA 08/2025 60 tablets 01/12/2023
369421/BA 08/2025 60 tablets 01/12/2023
369421/BB 08/2025 60 tablets 25/01/2024
371089/BA 07/2025 60 tablets 01/02/2024
367482/BA 07/2025 60 tablets 01/02/2024
369420/BB 08/2025 60 tablets 01/02/2024
380087/BA 02/2026 60 tablets 05/02/2024
357677/BA 01/2025 60 tablets 12/03/2024
346651/BA 09/2024 60 tablets 02/04/2024
366635/BD 07/2025 60 tablets 08/04/2024
371089/BB 07/2025 60 tablets 11/04/2024
371016/BA 08/2025 60 tablets 11/04/2024
369420/BC 08/2025 60 tablets 11/04/2024
379799/BA 12/2025 60 tablets 11/04/2024
380087/BB 02/2026 60 tablets 11/04/2024
381719/BA 02/2026 60 tablets 11/04/2024
369421/BC 08/2025 60 tablets 23/04/2024
380089/BB 02/2026 60 tablets 23/04/2024
371016/BB 08/2025 60 tablets 24/04/2024
380089/BA 02/2026 60 tablets 24/04/2024

Active Pharmaceutical Ingredient: Levetiracetam

Brief description of the problem

The MA holder, Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on above parallel imported packs which have been repackaged by BModesto B.V. Approximately 70% of the packs across the listed batches have been repackaged with the Braille message on the Keppra 500mg film-coated tablets incorrectly stating strength as 1000mg.

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.

View full alert here.

Advice for patients

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.

Further Information

For medical information and stock control enquiries please contact Doncaster Pharma on telephone: 01302 365 000.
Email  quality.enquiries@doncasterpharma.co.uk or commercial@doncasterpharma.co.uk

Capture healthcare advisory work not being covered by Pharmacy First to inform our negotiations with Government and NHS.

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