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IKERVIS 1 mg/mL eye drops recall

Particulates found during stability testing

September 22nd 2021

Tagged: Dispensary guidance news MHRA alert

By MHRA

SANTEN Oy (trading as Santen UK Limited) is recalling two batches of IKERVIS 1 mg/mL eye drops as a precautionary measure due to detection of particles/crystals of active ingredient ciclosporin during stability monitoring.

The presence of particles may cause ocular irritation, eye pain and foreign body sensation. A root cause investigation is ongoing.

The affected batches are:

Batch numberExpiry datePack sizeFirst distributed
1L49S05/202230 X 0.3ML09 October 2019
1N80G02/202330 X 0.3ML08 December 2020

Healthcare professionals are asked to stop supplying the above batches immediately. Please, quarantine all remaining stock and return it to your supplier using your supplier’s approved process. Patients should be advised to report any suspected adverse reactions via the MHRA Yellow Card Scheme

For more information, please contact Santen UK Limited, Salisbury Hall, St Albans, AL2 1BU, UK at +44 (0)1727 615 110 or email enquiries@santen.co.uk

For medical information queries, please contact 0345 075 4863 or email medinfo@santen.co.uk

For supply queries, please contact AAH Customer services at 0344 561 8899