“It is a precautionary measure”, specifies the Medicines Agency. The measure affects all valid batches of medicines manufactured in the Geymonat workshop in Latina. The company is at the heart of one scandal for the use of a false active ingredient in a drug also indicated for children.
05 SEP – "From the results of an investigation coordinated by the Public Prosecutor of Frosinone and conducted by the NAS Carabinieri of Latina jointly with the Italian Medicines Agency, which in June 2013 already led to the withdrawal of the batches of Ozopulmin produced by the Geymonat company, it resulted , albeit as a precautionary measure, the ban on the use of all currently valid batches of medicines (listed in the attachment) manufactured at the same Geymonat production workshop, due to suspected quality defects". This was communicated by a note from AIFA, which explains how it is "a precautionary provision, issued by AIFA pending the results of the extraordinary checks in progress, (extraordinary checks which as a precaution have been ordered for all the packages on the market produced by the company, for an estimated value of several million euros), adopted following constant monitoring actions aimed at reducing any risk, even if only hypothetical, for the health of patients, specifically linked to the possible presence of a quantity of lower active ingredient than that approved and indicated on the label".
"The packages of medicines belonging to the lots subject to the ban on use - explains the Agency - must be set aside pending the acquisition of the outcome of the technical investigations carried out by the Istituto Superiore di Sanità, which could lead to the revocation of the AIFA provision if the total absence of quality defects should be ascertained. In this case, the packs could still be usable within the expiry date shown on the label".
On the other hand, if a problem relating to the quality of the medicines subject to the precautionary measure is confirmed, the lots will be definitively withdrawn from the market.
“At the moment – explains Aifa – medicines are blocked in pharmacies or wholesalers. Those who have packs at home are in
