The company observed N-nitroso-quinapril, a nitrosamine, in the drug during recent acceptable daily intake level testing. Nitrosamines, which are common in water and foods, can increase cancer risk if exposure is over acceptable levels for an extended period of time.
Pfizer is not aware of any adverse event reports that have been assessed to be related to the recall to date.
“Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” the recall said. “Patients currently taking the products should consult with their doctor or healthcare provider about alternative treatment options for them.”
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.