MHRA Alerts Missing Safety Info for Tuzulby Prolonged‑Release Tablets

Neuraxpharm UK Ltd has notified the Medicines and Healthcare products Regulatory Agency (MHRA) that safety information is absent from the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC) for specific batches of Tuzulby prolonged‑release tablets (20 mg, 30 mg and 40 mg). The omission pertains to essential safety data that healthcare professionals and patients rely on when prescribing and using the medication. The MHRA classified the notification as a Class‑4 medicines defect, which requires the marketing authorization holder to take corrective actions. Neuraxpharm UK Ltd is required to update the affected PILs and SmPCs, inform distributors, and ensure that any remaining stock with the incomplete documentation is either corrected or withdrawn from the market. Stakeholders are advised to verify the batch numbers of Tuzulby tablets in their inventory and to monitor communications from Neuraxpharm for updated safety information. The agency will continue to monitor the situation to ensure compliance and patient safety. --- Source: MHRA (gov.uk)