Class 2

Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited), IKERVIS 1 mg/mL eye drops, emulsion, EL (21)A/22

SANTEN Oy (trading as Santen UK Limited) are recalling two 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 batches:

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

Brief description of problem

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. These particles have been detected following microscopic evaluation during stability monitoring. The company’s root cause investigation is ongoing.

Advice to Healthcare Professionals

Stop supplying the above batches 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. Whilst the Marketing Authorisation Holder have not received any reports of adverse reactions being caused by the presence of particles in the above batches, 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 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

To access the full recall: Class 2 Medicines Recall: SANTEN Oy (trading as Santen UK Limited) IKERVIS 1mg/ml eye drops, emulsion, EL (21)A/22