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The company is recalling blood pressure pills due to potential impurity




Lupine Pharmaceuticals issued a voluntary recall of some blood pressure medications due to the potential presence of a nitrosamine impurity, according to a notice published on the Food and Drug Administration’s (FDA) website.

The recall, issued last week, includes one lot of 20-milligram Quinapril tablets USP – G102929 – and three lots of 40-milligram Quinapril tablets USP ̵[ads1]1; G100533, G100534 and G203071, the notice said.

Consumers, wholesalers, distributors and retailers can find the batch number on the side of the label attached to bottles.

BLOOD PRESSURE MEDICATIONS RECALLED BECAUSE OF CHEMICAL’S POSSIBLE LINK TO CANCER

Lupine Pharmaceuticals said during recent tests that the presence of N-Nitroso-Quinapril had been “observed” at a level “above the Acceptable Daily Intake (ADI) level.”

Nitrosamines, commonly found in water and certain foods, “may increase the risk of cancer if people are exposed to them above acceptable levels for long periods of time,” according to the recall notice. The company said that all humans are “exposed to some level” of these impurities.

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There have been no illnesses related to the recall reported to Lupine so far, according to the notice. The affected tablets, distributed throughout the country, are for high blood pressure treatment.

FDA

A Food And Drug Administration sign outside its headquarters on July 20, 2020, in White Oak, Md. (Sarah Silbiger/Getty Images/Getty Images)

People taking 20-milligram or 40-milligram Quinapril tablets USP should continue taking their medications and consult their medical providers for an alternative treatment, Lupine Pharmaceuticals said.

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In addition to a written recall notice, the company calls wholesalers, distributors, drug chains, mail order pharmacies and supermarkets to inform them of the recall. Lupine Pharmaceuticals said in the release that it would “immediately” stop distributing the affected tablets.

It also arranges for all the affected lots to be returned, according to the notice.



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