Lupin arm recalls high BP drug Quinapril in US over presence of nitrosamine impurity

Lupin Pharmaceuticals Inc, the company's wholly-owned arm, is recalling the said tablets due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the acceptable daily intake (ADI) level, Lupin Ltd said in a regulatory filing.

"To date, Lupin has received no reports of illness that appear to relate to this issue," it said, adding it discontinued marketing of Quinapril tablets in September 2022.

Quinapril tablets of strengths 20mg and 40mg packaged in separate 90-count bottles were distributed nationwide in the US to wholesalers, drug chains, mail-order pharmacies, and supermarkets, it added.

The filing further said Lupin Pharmaceuticals Inc is notifying its wholesalers, distributors, drug chains, mail-order pharmacies, and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots while asking them to discontinue distribution of the recalled lots immediately.

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The company, however, advised patients taking the Quinapril tablets "to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment".

"This recall is being conducted with the knowledge of the US Food and Drug Administration," it added.

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The company said nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables.

While 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, it added.