The marketing authorisation holder for Klonazepam Remedica, tablets, 30x2mg, manufactured by Remedica Limited, Cyprus, has informed the Institute for Medicines and Medical Devices (CInMED) of the voluntary recall of the medicinal product from the market.

The recall is being carried out as a precautionary measure following the identification, during routine stability testing of the medicinal product, of results that were outside the approved specification. Based on the currently available data, the identified deviations do not indicate a risk to patient safety.

The marketing authorisation holder has informed CInMED that, following the recall, it will not be able to continue the regular supply of this medicinal product to the market until a new formulation is registered.

In order to ensure continuity of access to therapy, CInMED is currently conducting a procedure for the approval of an import of a clonazepam-containing medicinal product from another manufacturer.

Patients are advised not to discontinue the use of the medicinal product and, should they have any questions regarding their current therapy, to consult their doctor or pharmacist.