Recalled Drug Consists of Another Impurity, Says the FDA

According to the latest report, the United States Food and Drug Administration has found another impurity in a bunch of drugs that were recalled sometime back. These valsartan-based drugs were tested positive for an unexpected impurity, which was not among the reasons for the primary recall. The drugs are being made by Torrent Pharmaceuticals. N-nitrosodimethylamine, or NDMA was found in these drugs. This impurity can be cancerous according to the US Environmental Protection Agency. Upon this finding, several drugs that do contain valsartan were recalled by the FDA. It should be noted that all valsartan drugs are not being recalled, and FDA keeps an updated list.

N-nitrosodimethylamine, or NDMA is not a component that is intentionally added to the drugs. On the other hand, it’s an organic component that may be introduced to the drugs as a part of some chemical reactions. Manufacturing of some pesticides and processing of fish can result in the creation of this component, which is also used as a part of rocket fuel. However, the question how N-nitrosodimethylamine, or NDMA made it to these drugs remains. According to the latest reports, the three drugs from Torrent Pharmaceuticals also contain N-Nitrosodiethylamine, or NDEA, which is another carcinogen.

The FDA has given proper instructions on how to deal with things if you are consuming one of the recalled drugs. FDA recommends that you should talk to your doctor before making changes to the routine. Until a viable replacement is given, consumption of the recalled medicine should continue. “As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they’re not present in other products. We’re also taking steps to make sure we’re providing stringent oversight of manufacturing processes to reduce the likelihood that impurities could be introduced into other products”, said FDA.

Celso Gomes

Over 4 years’ experience in the research industry. Experience with research and consulting projects, catering to domains such as ICT, Health & Pharma, and packaging. Managed projects on both B2B as well as B2C perspective, which includes consumer preference analysis, interviews with key executives, etc.