The story of the withdrawal of the drug Augmentin which began last January:
In reality, as we wrote at the time, the story is true but it refers to a provision issued in 2014 and in the meantime the withdrawal has ended. The Aifa provision concerned packs of 12 coated tablets 875+125 mg. The withdrawal was ordered following reports from the companies GlaxoSmithKline and Medifarm, concerning internal labels in Romanian. Above all, the announcement of the withdrawal is dated December 5, 2014:
“05 DIC – L’AIFA trasmette un provvedimento concernente il ritiro di una partita del medicinale “AUGMENTIN 12 compresse rivestite 875+125 mg”, AIP n. 039785047. Il ritiro è stato disposto a seguito delle segnalazioni da parte delle ditte GlaxoSmithKline e Medifarm, concernenti etichette interne in lingua rumena. Nelle more del ritiro il medicinale non potrà essere utilizzato”.
As in the case of Bisolven, therefore, the withdrawal concerns only a few well-specified lots. The problem, as reported in the letter, lies only in the fact that the internal labels are not in Italian.