The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has reported the withdrawal of two batches of ‘IKERVIS’ eye drops in single-dose containers due to the presence of microcrystals of active principle and obtaining an out-of-specification result in the titration test.
‘Ikervis’ contains the active substance, cyclosporine. Cyclosporine is part of a group of medicines called immunosuppressants, which are used to reduce inflammation. This medicine is used to treat adults with severe keratitis (inflammation of the cornea, the clear layer in the front of the eye). It is used in those patients with xerophthalmia ( dry eye disease ) that has not improved despite treatment with artificial tears.
Specifically, these are the batches: 1L14T with expiration date 05/31/2022 and 4N78C with expiration date 05/31/2023 , of ‘Ikervis’ of 1 mg / ml eye drops in emulsion 30 single-dose containers of 0.3 ml. The marketing authorization holder is Santen OY, the manufacturer is Excelvision and the local representative is Santen Pharmaceutical Spain.
The AEMPS has informed the distribution and dispensing chain and has ordered the withdrawal from the market of all the distributed units of the affected batches and return to the laboratory through the usual channels.