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Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.
Pfizer has issued a voluntary nationwide recall of five lots of Accupril (Quinapril HCl) tablets distributed by Pfizer due to the presence of a nitrosamine, N-nitroso-quinapril, that is above the Acceptable Daily Intake (ADI) level.
Accupril is meant to lower blood pressure to treat hypertension, as well as for the management of heart failure as adjunctive therapy in addition to conventional therapy such as diuretics and/or digitalis. Pfizer is not aware of any adverse events that have been assessed to be related to this recall.
Nitrosamines are common and everyone is exposed to some level of them. However, if exposed to them above acceptable levels over long periods of time, they may increase the risk of cancer. While long-term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk, Pfizer states that there is no immediate risk to patients taking this medication. Patients currently taking this product should consult with their health care provider about alternative treatment options.
The product lots, DR9639, DX8682, DG1188, DX6031, and CK6260, were distributed nationwide to wholesalers and distributers in the United States and Puerto Rico from December 2019 to April 2022. Pfizer has notified direct consignees by letter to arrange for return of the recalled product and urges any entities with existing inventory of the lots to cease distribution and quarantine the product immediately. The recall is being conducted with the knowledge of FDA.