A defect notice has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) for certain batches of Topiramate Zydus Pharmaceuticals UK 20mg/ml Oral Solution after an error was identified on the outer carton and patient information leaflet (PIL).
The product (PL: 58839/0026) is a prescription-only medicine licensed for use in both adults and children. Topiramate is typically used to treat epilepsy and migraine.
The affected 150ml and 280ml packs are missing instructions to ‘shake well prior to opening and before each use’.
The defect notification applies to the following batches:
- TPR24001 – 280ml – expiry June 2026 – first distributed 11 November 2024
- TPR24002 – 280ml – expiry June 2026 – first distributed 11 November 2024
- TPR24003 – 150ml – expiry September 2026 – first distributed 29 November 2024
No recall is being undertaken and healthcare professionals are advised to continue prescribing and dispensing the affected batches.
However, they should inform patients that the medicine must be shaken well before opening and before each use.
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