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

To date, Lupin has received no reports of illness that appear to relate to this issue.

Lupin discontinued the marketing of Quinapril tablets in September 2022.

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Nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables.

Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure.

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Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below:

ProductLot NoExpiryNDCUPCDistribution DatesQuinapril Tablets USP, 20mgG10292904/202368180-558-09(90’s)36818055809503/15/2021         –09/01/2022Quinapril Tablets USP, 40mgG100533G100534G20307112/202212/202203/202468180-554-09(90’s)368180554097

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).

Product Label: (see images below)

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