Lupin Pharmaceuticals voluntarily recalls four lots of Quinapril Tablets

23 Dec 2022 , 10:43 AM

Lupin Limited informed that Lupin Pharmaceuticals Inc. is voluntarily recalling 4 lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, above the Acceptable Daily Intake (ADI) level in recent testing. 

Lupin has received no reports of illness that appear to be related to this issue to date.

Lupin discontinued selling Quinapril tablets in September 2022.

Nitrosamines are generally found in water and foods such as cured and grilled meats, dairy products, and vegetables. Nitrosamines are present in everyone’s environment. If people are exposed to these impurities at levels above acceptable levels for an extended period of time, they may increase their risk of cancer, said the company on Thursday.

Tablet containing quinapril USP is an angiotensin-converting enzyme (ACE) inhibitor used to treat hypertension by lowering blood pressure. Lowering blood pressure lowers the risk of both fatal and nonfatal cardiovascular events, most notably strokes and myocardial infarctions.

Quinapril Tablets USP 20mg and 40mg are packaged in 90 count bottles and are sold to wholesalers, drug chains, mail order pharmacies, and supermarkets throughout the United States.

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