Company recalling blood pressure pills because of potential impurity presence

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Lupine Pharmaceuticals has announced a voluntary recall of some blood pressure medications due to the possible presence of nitrosamine impurities, according to a notice posted on the U.S. Food and Drug Administration’s (FDA) website.

The recall, issued last week, includes one batch of 20 mg quinapril tablets USP (G102929) and three batches of 40 mg quinapril tablets USP (G100533, G100534, and G203071).

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

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Lupin Pharmaceuticals said during recent testing, the presence of N-nitroso-quinapril was “observed” at levels “above the Acceptable Daily Intake (ADI) level.”

Nitrosamines, commonly found in water and certain foods, “may increase the risk of cancer when people are exposed above tolerable levels for long periods of time,” according to the recall notice. He said that people are “exposed to some level” of these impurities.

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According to the notice, there have been no recall-related illnesses reported to Lupine so far. The affected tablets distributed nationwide are for treating high blood pressure.


The Food and Drug Administration sign outside its corporate headquarters in White Oak, Maryland, July 20, 2020. (Sarah Silbiger/Getty Images/Getty Images)

People taking 20 milligrams or 40 milligrams of Quinapril Tablets USP should continue to take their medication and talk to their healthcare provider about alternative treatments.

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In addition to written recall notices, the company calls wholesalers, distributors, drug chains, mail-order pharmacies and supermarkets to inform them of the recall. Lupine Pharmaceuticals said in a release that distribution of the affected pills should stop “immediately.”

We are also making arrangements for the return of all affected batches, according to the notice.

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