Hypertension Tablets Recalled for Nitrosamine Impurity

Lupin Pharmaceuticals Inc is recalling 4 lots of 20- and 40-mg quinapril tablets due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, above the acceptable daily intake limit. The recall was included in the December 28, 2022, US Food and Drug Administration (FDA) Enforcement Report.

“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables,” Lupin Pharmaceuticals stated in a December 21, 2022, company announcement. “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

The recall affects the following products, which were manufactured for Lupin Pharmaceuticals, Baltimore, Maryland, by Lupin Limited, Goa, India, and distributed throughout the United States:

• quinapril tablets, 20 mg, 90-count bottles (NDC 68180-558-09), from lot G102929 (Exp. 4/23); and
• quinapril tablets, 40 mg, 90-count bottles (NDC 68180-554-09), from lots G100533 (Exp. 12/22), G100534 (Exp. 12/22), and G203071 (Exp. 3/24).

Lupin Pharmaceuticals voluntarily initiated the recall December 7, 2022. On December 23, 2022, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

As of December 21, 2022, no reports of illness related to the recall had been reported to the company.

Quinapril is a prescription angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension. Lupin Pharmaceuticals discontinued marketing quinapril in September 2022.