Class 2

Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) IKERVIS 1 mg/mL eye drops, emulsion , EL (22)A/01

SANTEN Oy (trading as Santen UK Limited) are recalling the above batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin.

MDR Number: 268-08/21

Company name: SANTEN Oy (trading as Santen UK Limited)

Product description: IKERVIS 1 mg/mL eye drops, emulsion, EU/1/15/990/001

Details of the affected batch:

Batch number

Expiry date

Pack size

First distributed

4N46E

05/2023

30 X 0.3ML

March 2021

Brief description of problem:

SANTEN Oy (trading as Santen UK Limited) are recalling the above batch of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. These particles have been detected following microscopic evaluation during stability monitoring.

Following new investigations, SANTEN Oy are recalling the above batch additional to those recalled on 15 September 2021 (Reference EL (21)A/22) and 18 November 2021 (Reference EL (21)A/30).

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

The presence of particles may cause ocular irritation, eye pain and foreign body sensation. The Marketing Authorisation Holder are investigating reports of adverse reactions but these have not been confirmed to be caused by the presence of particles in the above batch. Healthcare professionals should advise patients to report any suspected adverse reactions via the MHRA Yellow Card scheme.

Company contacts for further information:

For more information, please contact +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

Full recall