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 number||Expiry date||Pack size||First distributed|
|1L49S||05/2022||30 X 0.3ML||09 October 2019|
|1N80G||02/2023||30 X 0.3ML||08 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 email@example.com
For medical information queries, please contact 0345 075 4863 or email firstname.lastname@example.org
For supply queries, please contact AAH Customer services at 0344 561 8899