Pfizer voluntarily recalls five more lots of BP medication for carcinogen risk
Pfizer issued a voluntarily nationwide recall of five lots of quinapril HCl/hydrochlorothiazide tablets due to the presence of a nitrosamine known to be carcinogenic in high doses.
According to a company announcement circulated by the FDA, N-nitroso-quinapril was found in higher than acceptable daily levels in five lots of quinapril HCl/hydrochlorothiazide tablets (Accupril) distributed by Pfizer in 10 mg, 20 mg and 40 mg doses. The medications are for lowering BP.
The product lots were distributed in the U.S. and Puerto Rico from December 2019 to April 2022.
As Healio previously reported, in March, the company previously recalled six lots of quinapril HCl/hydrochlorothiazide tablets (Accuretic), two lots of quinapril and hydrochlorothiazide and six lots of quinapril HCl/hydrochlorothiazide generics distributed by Greenstone, for the same reason.
Nitrosamines are common in water and certain foods; however, exposure to higher than acceptable levels over long periods of time may increase risk for cancer, according to the announcement.
Quinapril HCl/hydrochlorothiazide tablets are indicated for the treatment of hypertension as well as for the management of HF as adjunctive therapy when added to conventional therapy.
Pfizer is not aware of reports of adverse events related to this recall, according to the announcement.
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