Zentiva UK Pharma is recalling one batch of Fingolimod Zentiva 0.5 mg capsules as a precaution after possible small metal particles were identified during shelf-life testing, according to an MHRA Class 2 recall notice.
The affected batch is 4L01372H, supplied in packs of 28 and carrying an expiry date of November 2027. The regulator says the particles, if present, are small and pose a low risk to tablet safety or effectiveness; no reports of harm had been received when the notice was issued.
Healthcare professionals should stop supplying the affected batch, quarantine remaining stock and return it through the approved supplier process.
Patients who hold the affected batch should contact their pharmacy first. They should not stop taking fingolimod without speaking to a healthcare professional, and should seek medical advice if they experience an adverse reaction or have questions about their medicine.
