The FDA had found that the amounts of NDMA found in recalled batches of valsartan exceeded acceptable levels and based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. The agency wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA. Consuming ≤96 nanograms NDMA/day is considered reasonably safe in humans. It is estimated that over course of person’s lifetime, consuming this amount would result in <1 additional case of cancer per 100,000 people (currently 1 in 3 in US will experience cancer in their lifetime)
The affected products have also been recalled at a European level and the Committee for Medicinal Products for Human Use will investigate the levels of NDMA in them to establish possible impact on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches.