MHRA Class 2 Medicines Recall: Ikervis 1mg/ml eye drops emulsion (SANTEN OY trading as Santen UK Ltd)

MHRA Class 2 Medicines Recall: Ikervis 1mg/ml eye drops emulsion (SANTEN OY trading as Santen UK Ltd)

January 19, 2022

MDR Number: MDR 268-08/21

Date issued: 19 January 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall for IKERVIS 1 mg/ml eye drops, emulsion  (SANTEN Oy (trading as Santen UK Limited))

Brief description of the problem

SANTEN Oy (trading as Santen UK Limited) are recalling the below 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 below batch additional to those recalled on 15 September 2021 (Reference EL (21)A/22) and 18 November 2021 (Reference EL (21)A/30).

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

Batch Number Expiry Date Pack Size First Distributed
4N46E 05/2023 30 X 0.3ML March 2021

 

Advice for 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.

Further Information

Santen UK Limited

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

View alert here.



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