The Hellenic National Medicines Agency (EOF) decided the withdrawal of all production lots of the drug Ponstan syrup 50 mg/5 ml (Marketing Authorization Number 60079 /22-9-08) currently on the market due to the potential exceedance of the new limits of the Permitted Daily Exposure (PDE) in lead and lithium issued by the European Directive ICH Q3D.
According to EOF, Pfizer HELLAS SA must contact its customers directly to withdraw it from the market.
