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

SNOMED Code: N/A

Details of the affected batch: 

Brief description of 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 to 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 to 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

Company contacts for 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

To access the full recall: 

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