Pfizer has voluntarily recalled five lots of Accupril (Quinapril HCl) tablets due to the presence of N-nitroso-quinapril, a nitrosamine impurity, above the Acceptable Daily Intake (ADI) level.
Nitrosamines impurities are commonly found in water and foods, including cured and grilled meats, dairy products and vegetables.
If people are exposed to nitrosamines above acceptable levels over prolonged periods of time, the impurities may increase the risk of cancer.
Accupril is an ACE inhibitor that works by lowering the activity of the renin-angiotensin-aldosterone system to treat high blood pressure (hypertension).
The drug is also indicated for the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis.
Pfizer said that no reports of adverse events have been received to be related to the current recall, and the benefit/risk profile of the products currently remains positive.
The US drugmaker urged the patients, who are currently taking the products, to consult with their doctor or health care provider to receive alternative treatment.
The announcement follows the company’s voluntarily recall of the blood pressure drug Accuretic (quinapril HCl/hydrochlorothiazide), and two of its generic versions, last month.
Pfizer has recalled six lots of Accuretic, one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/ hydrochlorothiazide tablets, due to nitrosamine impurities.
In a separate development, Aurobindo Pharma, Sun Pharma and Jubilant are recalling different pharmaceutical products in the US for various reasons.
Aurobindo Pharma is recalling Cyanocobalamin Injection for vitamin B12 deficiency, Sun Pharma is recalling a drug used to enable the production of natural tears in eyes, while Jubilant Cadista is recalling a drug used to treat various inflammatory conditions.
Jubilant Cadista is a fully-owned pharmaceuticals subsidiary of Cadista Holdings, which is a part of the Noida-based Jubilant Life Sciences.
Aurobindo has recalled 4,33,809 vials of Cyanocobalamin injection, and Sun Pharma 73,030 boxes of Cequa (cyclosporine ophthalmic solution) for being Subpotent Drugs.
