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.
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 |
|---|---|---|---|
| 1L49S | 05/2022 | 30 X 0.3ML | 09 October 2019 |
| 1N80G | 02/2023 | 30 X 0.3ML | 08 December 2020 |
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 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 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
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
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.
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