To the attention of interested persons
NAMMD press release on market withdrawal, at wholesale distributor level, of CILEST 0.250mg/0.035mg, tablets.
This is to inform you on NAMMD decision following information received from the Belgian competent authority and the Marketing Authorisation Owner (Johnson & Johnson d.o.o.) via the rapid alert system, on recall at wholesale distributor level, of all CILEST 0.250mg/0.035mg, tablets batches manufactured as of January 2011.
This decision has been triggered by the Belgian manufacturer finding a quality concern in certain product batches (out-of-specification outcome under the „dissolution time” parameter for one of the two medicinal product active substances). Though unlikely, this quality defect could lead to lower contraceptive effect, given that the tablet is administered once a day only and, moreover, company analysis between 1 January 2009 and 31 December 2012 showed diminished number of reports received on lack of efficacy and occurrence of pregnancies.
For reasons of this medicinal product possible unavailability for some time, patients taking Cilest (tablets) are recommended to discuss alternative treatment with their physician.
This precautionary recall at wholesale distributor level of all Cilest 0.250mg/0.035mg, tablets, batches manufactured as of January 2011 is performed in all countries where the product is distributed, as well as in other EU Member States.