MHRA Class 2 Medicines Recall: Ikervis 1mg/ml eye drops emulsion (SANTEN OY trading as Santen UK Ltd)
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.
IKERVIS 1 mg/mL eye drops, emulsion, EU/1/15/990/001
|30 X 0.3ML
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.
Santen UK Limited
For more information, please contact +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
View alert here.