Impurities Lead to Lupin Recall of Quinapril

Lupin Pharmaceuticals is voluntarily recalling four lots of quinapril tablets because of the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the acceptable daily intake level. To date, Lupin has received no reports of illness that appear to relate to this issue.

Quinapril tablet is an angiotensin-converting enzyme (ACE) inhibitor that lowers blood pressure in patients with hypertension. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Lupin discontinued the marketing of quinapril tablets in September 2022.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Quinapril tablets 20 mg, and 40 mg is packaged in 90 count bottles and was distributed nationwide in the United States to wholesalers, drug chains, mail order pharmacies and supermarkets. The lots were distributed between March 15, 2021, and Sept. 1, 2022. Among the recalls are:

• Quinapril 20 mg with the lot number of G102929 and an expiration of April 2023; the NDC number is 68180-558-09
• Quinapril 40 mg with the lot number of G100533 and an expiration of December 2022; the NDC number is 68180-554-09
• Quinapril 40 mg with the lot number of G100534 and an expiration of December 2022; the NDC number is 68180-554-09
• Quinapril 40 mg with the lot number of G203071 and an expiration of March 2024; the NDC number is 68180-554-09