Drug major Pfizer Inc. has recalled five lots of Accupril (Quinapril HCl) tablets due to the presence of a nitrosamine, Nnitroso-quinapril, a probable human carcinogen, above the Acceptable Daily Intake or ADI level, the U.S. Food and Drug Administration said.
The recall includes Accupril (Quinapril HCl Tablets), 10 mg, 20 mg and 40 mg doses in 1 x 90 count bottles distributed to the patient level. The affected product lots are DR9639 with expiration date 2023 MAR 31; DX8682 with expiration date 2023 MAR 31; DG1188 with expiration date2022 MAY 31; DX6031 with expiration date 2023 MAR 31; and CK6260 with expiration date 2022 MAY 31.
The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.
Accupril is indicated for the treatment of hypertension, to lower blood pressure, as well as for the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.
The recall was initiated after the high level of Nnitroso-quinapril was observed in recent testing.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
However, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall to date.
The company urged patients who currently take the affected products to consult with their doctor or health care provider about alternative treatment options for them.
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