Lupin Pharmaceuticals Inc. is voluntarily recalling four lots of Quinapril tablets in the U.S. to the patient level.
It follows the presence of a nitrosamine impurity observed in recent testing above the acceptable daily intake level, the wholly owned U.S. subsidiary of Lupin said. The tablets were manufactured by Lupin in Goa.
An angiotensin-converting enzyme inhibitor, Quinapril tablet USP is indicated for the treatment of hypertension. Lupin said it has discontinued the marketing of Quinapril tablets in September. While nitrosamines are common in water and various foods, these impurities may increase risk of cancer if people are exposed to them above acceptable levels over long periods of time, the company said.