The Main Pharmaceutical Inspectorate of Poland received a protocol from the tests carried out at the Polish National Medicines Institute, which shows that the tested samples of the green boxes of Tabex 1.5 mg, coated tablets with batch number 31120, manufactured under license by Sopharma Warszawa sp. Z oo, does not meet the specification requirements for the parameter of impurity content (in terms of the content of N – formylcitisine).
As a result of the submitted explanations, the responsible entity Sopharma Warszawa sp. Z oo with its seat in Warsaw (KRS No. 0000372245) confirmed the obtained result and informed about the need to withdraw the green boxes Tabex from the market.
In connection with the finding of the quality defect referred to above, the Main Pharmaceutical Inspector from Poland decided to withdraw from the market the batch of the medicinal product Tabex in green boxes, manufactured under license by Sopharma Warszawa sp. Z oo.
Therefore always buy the original Tabex in blue boxes from Sopharma Bulgaria.
📢 GIF wycofuje z obrotu na terenie całego kraju produkt leczniczy
Tabex (Cytisinum); 1,5 mg; tabletki powlekane;
numer serii: 31120; termin ważności: 11.2022;
podmiot odpowiedzialny: Sopharma Warszawa sp. z o.o.👇 https://t.co/HeYppkf3D6
— Główny Inspektorat Farmaceutyczny (@GIF_GOV_PL) December 27, 2021