Class 4 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15

Source: MHRA / Gov.uk 15.5.24

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

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

There is no issue with the quality of the tablets, therefore, the affected batches are not being recalled. We would advise healthcare professionals to check, before dispensing the medication, whether patients or carers handling or taking the medication will be relying on the Braille. Where this is the case, alternative batches should be dispensed to avoid confusion and subsequent underdosing.

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 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

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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Class 4 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL (24)A/15

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