Notification of voluntary recall of two series of the drug Ultraproct mast


The Agency for Medicinal Products and Medical Devices has received notification from the marketing authorisation holder Bayer d.o.o. about the voluntary recall from the market of two series, nos. 11108B and 14118B, of the drug Ultraproct ointment due to irregularities in quality observed during testing of drug stability.

The test results indicated a greater quantity of cinchocaine-N-oxide, a breakdown product of cinchocaine chloride, than listed in the medicinal product specifications. According to the available non-clinical and clinical data, a pharmacovigilance risk assessment was conducted with the conclusion that there are no doubts as to the safety and efficacy of the drug, and that no risk should be expected for users during use of the affected series of the drug. Therefore, the drug is being recalled at the wholesale level, as stated in the recall notification issued by the marketing authorisation holder.

The marketing authorisation holder, the company Bayer d.o.o., has informed HALMED that for the said reasons, a shortage in the drug Ultraproct ointment on the market of the Republic of Croatia can be expected until the drug can be resupplied, which is expected in the second quarter of 2012.