AIFA precautionary ban drugs produced by Geymonat - International

Into (ASCA) – Rome, September 5 – The Italian Medicines Agency (AIFA) has issued a ban on use of all lots in the course of validity ‘of medicinal products manufactured at the workshop production Geymonat of Anagni ( Fr), due to suspected quality defects’. This was communicated by AIFA in a note stating that the measure has a “precautionary” and that it ‘resulting from the results of the survey coordinated by the prosecutor in Frosinone and conducted by the NAS Carabinieri of Latin America, jointly Italian Medicines Agency, which has already ‘led to withdrawal in June, lots of Ozopulmin produced by the firm Geymonat.

Into The AIFA reports having issued precautionary measure, pending the outcome of the special verification in progress (special controls that, as a precaution, have been arranged for all packages produced on the market company, worth estimated several million euro), adopted as a result of constant monitoring actions aimed at reducing any risk, even if only hypothetical, for the health of patients, specifically relating to the possible presence of a quantity of active ingredient less than the approved and indicated on the label.

Into The packaging of medicines in the lots covered by the prohibition of use must be earmarked to acquire the outcome of the technical analyzes performed by the National Institute of Health ‘, which could lead to the lifting of the AIFA should it be ascertained total absence of defects in quality ‘.

Into In this case, packages might still be usable until the expiration date stated on the label.

Into Where, however, is confirmed a problem with the quality ‘of medicines covered by precautionary measure, all items will be permanently removed from the market.

Into At the time, the medicines are locked in pharmacies or from wholesalers.

Into Those who were to have in the house of the packs are advised not to use pending completion of the investigation: the evolution of the situation will be ‘promptly notified.

Into This is a news agency Reuters.