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.
Company name
SANTEN Oy (trading as Santen UK Limited)
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 |
Active Pharmaceutical Ingredient: ciclosporin
MDR number
268-08/21
Brief description of the 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 for 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.
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
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Download document