Pfizer Issues Voluntary Nationwide Recall for Lots of Quinapril HCI Due to N-Nitroso-Quinapril Content

Patients taking the product should consult with their physician or pharmacist to determine whether they have the affected product.

Pfizer is voluntarily recalling 5 lots of quinapril HCI (Accupril) tablets distributed to the patient level due to the presence of the N-nitroso-quinapril nitrosamine, observed in recent testing above the acceptable daily intake (ADI) level.

Nitrosamines are common in water and various foods, including cured and grilled meats, dairy products, and vegetables, according to a Pfizer press release. Despite the fact that everyone is exposed to some level of nitrosamines, these impurities can increase the risk of cancer in individuals exposed to them above acceptable levels over long periods of time.

Accupril is indicated for the treatment of hypertension and in the management of heart failure as adjunctive therapy when added to conventional therapies, such as diuretics or digitalis. Accupril has a safety profile that has been established for more than 30 years, according to the press release. To date, Pfizer is not aware of reports of adverse events assessed to be related to this recall.

According to the press release, Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. 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. Patients currently taking Accupril should consult with their health care provider about alternative treatment options.

The lot numbers recalled are DR9639, DX8682, DG1188, DX6031, and CK6260. Wholesalers and distributors with an existing inventory of these lots should stop use and distribution and should quarantine the product immediately, according to the press release. Patients taking the product should consult with their physician or pharmacist to determine whether they have the affected product.

REFERENCE

Pfizer Voluntary Nationwide Recall of Lots of Accupril (Quinapril HCI) Due to N-Nitroso-Quinapril Content. News release. Pfizer; April 22, 2022. Accessed April 25, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril