NDMA: a recall trigger for the drug development industry
Posted: 25 August 2020 | Marc Baiget Francesch (International Journal of Molecular Sciences) | No comments yet
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
N-nitrosodimethylamine (NDMA) is one of the main compounds responsible for pharmaceutical product recalls. This year, 12 US Food and Drug Administration (FDA)-regulated drug products have already been recalled1 and, according to the administration’s records, 1,159 lots of these particular drugs have been affected by an FDA recall due to dangerous levels of nitrosamides such as NDMA.2 The FDA is not the only regulatory agency that has shown concern for nitrosamide contamination. The US Environmental Protection Agency (EPA) has regarded NDMA as a priority pollutant and last September the European Medicines Agency (EMA) initiated a review to advise marketing authorisation holders on how to prevent contamination by these agents.3