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Higher than normal levels of nitrosamine have been detected. Long-term exposure to high amounts of nitrosamine can lead to cancer.
Pfizer is voluntarily recalling five lots of Accupril (quinapril HCl) tablets because of the presence of a nitrosamine, Nnitroso-quinapril, a cancer-causing chemical, above the acceptable daily intake level.
Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Pfizer is not aware of reports of adverse events related to this recall.
Accupril is approved to lower blood pressure, as well as for the management of heart failure when added to conventional therapy. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
For lot and NDC number involved in this recall, visit the FDA site here.