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