article

NDMA: a recall trigger for the drug development industry

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.

World map overlaid with a bottle of pills and a syringe being inspected by a magnifying glass labelled FDA

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











To read this article in full, please complete the form below. By clicking submit you confirm that you accept our terms and conditions and privacy policy.


*

*

*

*

*

*

*

*

This content is provided to you for free thanks to the kind support of our sponsors: SUEZ and MilliporeSigma

Send this to a friend