The news was known and we have it published on 12/12/2014 along with other “defective” drugs. Some batches of medicines Torastin and Furosemide Salf and ADESITRIN 15 mg/24 h transdermic patches have also been withdrawn.
The Italian Medicines Agency (Aifa) has ordered the withdrawal of the batches of the antibiotic drug Augmentin 12 coated tablets 875+125 mg, coming from "parallel import" with indications in the package leaflet and internal labels in Romanian.
The information reached pharmacies and distributors, but the Federconsumatori association writes in a note, "the citizens were not warned". And he adds: «In the face of irregularities in the production of widely consumed drugs, it is surprising that we have only recently come to know of a provision dated 5 December 2014 which forced purchases to be halted but did not give patients indications not to use the drug from Romania".
The Aifa note indicates that the withdrawal concerns Aip lots no. 039785047 with internal labels in Romanian and "was arranged following reports from the companies GlaxoSmithKline and Medifarm". According to Federconsumatori «the alarm that forced pharmacies to block the sale and use of the well-known antibiotic has inexplicably ignored citizens.
Those who bought the suspect products before the withdrawal were not informed at all about the risks of using them.' And he adds: «The question arises spontaneously: why were the citizens not warned? Why weren't they asked to check the product packaging in their possession? It is necessary to clarify and reaffirm the maximum commitment to avoid exposing citizens to health risks".
Ed.: the news was known and the more attentive readers of this site will in fact remember that we published it on 12 December 2014 in the article Defective medicines withdrawn
Related news: FOFI release
Aifa orders the withdrawal of some lots of medicines Torastin and Furosemide Salf
The measure concerns Torastin 10 mg and 20 mg film-coated tablets 30 tablets. Furosemide Salf was withdrawn following reports concerning difficulties in opening the vials with cases of breakage in the hands of the operator.
08 JAN – The Pharmacist – Aifa has sent a provision ordering the withdrawal of:
− TORASTIN 10 mg film-coated tablets 30 tablets, AIC 040129049/M, lots no. C305065, C309103, C404781, Farmaceutici Caber SpA;
− TORASTIN 20 mg film-coated tablets 30 tablets, AIC 040129102/M, lots no. C305066, C309104, C404782, Farmaceutici Caber SpA;
− TORASTIN 40 mg film-coated tablets 30 tablets, AIC 040129153/M, lots no. C303411, C401798, Farmaceutici Caber SpA. The drugs were withdrawn following the company's report concerning possible out-of-specification results.
− FUROSEMIDE SALF 5 vials 20 mg/2ml, lot no. A4G051, company SALF Laboratorio Farmacologico SpA. The drug was withdrawn following reports concerning difficulties in opening the vials with cases of breakage of the same in the hands of the operator.
Pending collection, the lots in question cannot be used.
08 January 2015
Aifa orders withdrawal of medicinal lots "ADESITRIN 15 mg/24 h transdermic patches"
|The measure it was released following a report from the company, Pfizer, concerning out-of-specification results during stability studies performed on the drug.
31 DEC – AIFA has ordered the withdrawal of some lots of the medicine “ADESITRIN 15 mg/24 h transdermal patches”, AIC n. 026068039 of the Pfizer company, following the report from the company, concerning out-of-specification results during stability studies carried out on the drug.