Drug major Pfizer Inc. has recalled certain lots of blood pressure drug Accuretic tablets as well as two authorized generics due to the elevated levels of nitrosamine, N-nitroso-quinapril content, a probable human carcinogen.
The recall involves six lots of Accuretic (quinapril Hcl/hydrochlorothiazide) tablets, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets to the patient (consumer/user) level.
Accuretic was distributed by Pfizer, while the two authorized generics quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide were distributed by Greenstone.
The product lots were distributed to wholesalers and distributors across the United States and Puerto Rico from November 2019 to March 2022. Earlier this month, Pfizer Canada recalled Accuretic indicated for the treatment of hypertension due to the same concern.
Nitrosamines are generally found in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines, but exposure to the impurities in higher levels over long periods of time may increase the risk of cancer.
However, Pfizer has not received any reports adverse events related to the recalled drugs to date.
According to the company, the benefit/risk profile of the products remains positive based on currently available data. Though there is no immediate risk to patients taking this medication, they are urged to consult with their doctor about alternative treatment options.
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