Four batches of Levetiracetam ‘missing safety information’

A defect notification has been issued for specific batches of Levetiracetam Accord 100mg/ml oral solution because they are missing some safety information.

Accord Healthcare Limited UK has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) for four batches of the epilepsy medication ‘do not contain all the required safety information’.

Issued by the MHRA, the notification affects Levetiracetam Accord 100mg/ml oral solution – batch numbers E243884, E244160, and E243885 which expire on 31 August 2027, and batch E244161 which expires on 30 September 2027. Batch number E243885 is the only one to have been distributed and this began on 16 January 2025.

The quality of the oral solution is not impacted by this issue and therefore the batches are not being recalled.

The information missing from the PIL and SPC is summarised in the Appendix of the medicines defect notification, and links to the correct PIL and SPC are also provided.

The MHRA, in discussion with the Department of Health and Social Care (DHSC), considers these products critical for patients and therefore, the batches listed as ‘not yet distributed’ will be distributed without further repackaging.

Healthcare professionals have been advised to signpost new patients on these medications to the missing safety information.

Upon request, Accord Healthcare Limited will provide hard copies of the updated PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information.

Patients have been advised to continue taking medications as prescribed by their healthcare professional.

Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.