Pfizer (NYSE:PFE) has announced a voluntary recall of five lots of Accupril (Quinapril HCl) tablets owing to elevated levels of the nitrosamine N-nitroso-quinapril.
Accupril, an angiotensin-converting enzyme (ACE) inhibitor, is indicated for treating hypertension. FDA has also approved its use as an adjunctive therapy for treating heart failure.
N-nitroso-quinapril, which can be frequently found in water and some foods in low levels, may pose a cancer risk in higher levels.
Pfizer concluded that the nitrosamine in certain Accupril lots was above the acceptable daily intake value.
The company has not observed adverse event reports related to the elevated levels of N-nitroso-quinapril in some lots.
Pfizer reports that the affected lots were distributed in the U.S. and Puerto Rico from December 2019 to April 2022.
In recent years, FDA has exerted pressure on the pharmaceutical industry to test potentially hundreds of medications for nitrosamine.
Based on FDA’s requested review, Pfizer has identified issues with Chantix, Metformin, Zantac and Accuretic, among others.
The Novartis subsidiary Sandoz recently recalled 13 lots of orphenadrine citrate after detection of nitrosamine impurities.