Two batches of Ikervis 1mg/ml ciclosporin eye drops recalled
June 8 2016
Santen UK has recalled two batches of its Ikervis (ciclosporin) emulsion 1 mg/ml eye drops, in packs of 30 0.3ml single dose containers.
The Class 2 Drug Alert has been issued because micro particles of the active ingredient were found in stability test samples.
The affected batches both have an expiry date of October 2018, and their batch numbers are:
• batch number 9D65E, first distributed January 21 2016
• batch number 9D65K, first distributed February 24 2016
“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,” said the medicines regulator, the MHRA.
“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.”