Lupin announced that it has voluntarily recalled four lots of Quinapril tablets due to the presence of a nitrosamine impurity observed in recent testing above the acceptable daily intake (ADI) level.
Lupin said that till date, it has not received any reports of illness that appear related to this issue. Lupin however, discontinued the marketing of Quinapril tablets in September 2022.In an exchange filing, the drug maker said 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 is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Quinapril Tablets USP 20mg, and 40mg was packaged in 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets.
Lupin Pharmaceuticals has notified 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.
Patients taking, Quinapril tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
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On consolidated basis the company reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Revenue from operations rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as compared to Rs 4,003.42 crore in Q2 FY22.
The scrip rose 1.13% to Rs 777 on the BSE.
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