Class 3 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15

Source: MHRA / Gov.uk 22.5.24

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.

MDR number

MDR 082-05/24

Company name

Doncaster Pharma Limited

Product name

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

SNOMED Code

N/A

Batch No 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.

Correct Braille

The correct Braille message should read:

Incorrect Braille

The incorrect Braille message reads as:

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.

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.

Further Information

For medical information and stock control enquiries please contact Doncaster Pharma on tel. 01302 365 000, email quality.enquiries@doncasterpharma.co.uk or commercial@doncasterpharma.co.uk

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 3 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15

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