Pfizer on March 21 issued a voluntary recall of its hypertension drug Accuretic and two generic versions of the drug because of elevated levels of a nitrosamine called N-nitroso-quinapril.
The drugmaker has recalled six lots of Accuretic tablets; one lot of quinapril and hydrochlorothiazide tablets distributed by Greenstone; and four lots of quinapril HCI/chlorothiazide tablets, also distributed by Greenstone.
"Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines," Pfizer said in a statement, noting the recall was issued after finding levels above the acceptable daily intake.
"These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time."
Pfizer said it is not aware of any adverse events related to the recall to date and that wholesalers and distributors with existing inventory of recalled lots should stop distributing the product immediately.
To view details on the recalled lots, click here.