LThe Italian Medicines Agency (AIFA) announces that it has endorsed the voluntary withdrawal by the company that holds the MA of METFORMINA MYLAN GENERICS tablets, in the different dosages, lots specified in the attached provision. The withdrawal is precautionary, is not related to safety or efficacy issues and was issued following an inspection carried out by the Portuguese authority (Infarmed) at the manufacturing plant of the medicine in India which highlighted the non-compliance with the Good Manufacturing Practices (GMP) of the production site. At the moment in the Net of Pharmacovigilance there are no reports of adverse reactions to medicinal products in matters that may be related to the quality defects found by the Portuguese agency.
