Ikervis 1 mg/ml eye drops, emulsion (ciclosporin) - micro particles of active ingredient

(Santen UK Ltd) Two batches of Ikervis 1 mg/ml eye drops, emulsion (30 single dose containers) (ciclosporin), are being recalled because micro particles of the active ingredient were found in stability test samples (EL(16)A/07)

7 June 2016

Class 2 medicines recall

Action within 48 hours

Pharmacy and Wholesale Level recall

MDR 116-05/16

Product details

Santen UK Limited

Ikervis 1 mg/ml eye drops, emulsion (ciclosporin)

Batch Number Expiry date Pack Size First distributed
9D65E Oct 2018 30 x 0.3 ml 21 Jan 2016
9D65K Oct 2018 30 x 0.3 ml 24 Feb 2016

Alert details

Santen UK Ltd is recalling batch 9D65E & 9D65K of Ikervis (ciclosporin) 1 mg/ml eye drops emulsion, as micro particles of the active ingredient were found in stability test samples stored at 25 °C/60% RH for 6 months.

Advice for healthcare professionals and patients

Pharmacists and wholesalers are asked to return any remaining stock from these batches to their local AAH depot. All other batches of Ikervis are unaffected by this issue and alternative batches are available for the fulfilment of prescriptions. Patients who are using and have used Ikervis 1 mg/ml eye drops batch 9D65E and 9D65K do not need to return products to the pharmacy because no urgent safety issues have been identified.

Further information

For Medical Information, please contact telephone number 0345 075 4863 or email medinfo@santen.co.uk. For enquiries regarding returns please contact AAH Limited, telephone number 0844 5618899, and for stock queries, please call 01727 884523.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to ophthalmologists, relevant clinics, general practitioners and community pharmacists for information.

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Stanten UK Ltd - Ikervis 1 mg/ml eye drops, emulsion (ciclosporin) (EL (16)A/07)

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