In the words of Daft Punk, one more time. On October 25, the U.S. Food and Drug Administration (FDA) announced yet another blood pressure medicine recall for contaminants that may cause cancer, a problem that has occurred far too many times since 2017. This time the company is Aurobindo Pharma USA, Inc. The blood pressure medication being recalled is Quinapril and Hydrochlorothiazide Tablets USP in 20 mg and 12.5 mg doses, respectively. And the contaminant is Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril in levels that exceed acceptable limits.
This certainly isn’t a “we’re gonna celebrate” situation. Although nitrosamines can be found in water and foods such as cured and grilled meats, dairy products, and vegetables, ingesting nitrosamines repeatedly over a long periods of time can increase your risk of cancer. That’s why the FDA has established thresholds for accpeptable levels of nitrosamines in medication. Although there haven’t yet been any reports of adverse events related to the medications being recalled by Aurobindo Pharma USA, Inc. so far, the presence of too high levels of nitrosamines means that the company is gonna have to do it right and do some cleaning of its manufacturing processes.