Nitrosamine Impurities in Metformin-Containing Medicines: the Current Situation in Ukraine

Abstract

Introduction. In 2019–2020, global concern arose following the detection of N-nitrosodimethylamine (NDMA) in specific batches of metformin, prompting investigations and product recalls in numerous countries. These findings prompted national and international regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to conduct a series of investigations. As a result, many manufacturers took precautionary measures and voluntarily recalled the affected products. These recalls were based primarily on analytical results provided by regulatory authorities or independent laboratories that found NDMA levels exceeding the acceptable intake (AI) limits set by health authorities. The focus was mainly on metformin drugs in the form of extended- release (ER) tablets. Still, the situation with immediate-release (IR) tablets is almost not covered in official documents and scientific literature.