Drug maker Lupin has said that its U.S.-based arm is recalling four lots of blood pressure tablets in the American market due to the presence of a nitrosamine impurity, which may raise the risk of cancer if people are exposed to them above acceptable levels over long periods of time. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA), it said in a regulatory filing.
Reacting to the news, Lupin share price slipped slightly but rebounded. The pharma stock opened a tad lower at ₹766.45, against the previous closing price of ₹768.35 on the BSE. It declined as much as 1% to hit an intraday low of ₹760.70. However, the stock soon pared losses and rebounded 2.7% from low levels to ₹781.50. The market capitalisation stood at ₹35,498.6 crore at the time of reporting. In comparison, the BSE Sensex was trading 370 points lower at 60,456 levels.
“Lupin Pharmaceuticals Inc. is voluntarily recalling four lots of Quinapril Tablets to the patient level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level,” the company said in a BSE filing on Thursday.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines, but these impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time, Lupin said.
The company, however, added that it has not received any reports of illness related to this issue till date.
Lupin discontinued the marketing of Quinapril tablets in September 2022.
As per the company, Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Quinapril Tablets USP 20mg, and 40mg is packaged in 90 count bottles and was distributed nationwide in the U.S. to wholesalers, drug chains, mail order pharmacies and supermarkets.
Lupin Pharmaceuticals Inc., the U.S. arm of Lupin, notifies 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, it said. “Wholesalers, distributors, and retailers that have Quinapril Tablets USP, 20mg, and 40mg that are being recalled should discontinue distribution of the recalled product lots immediately,” it added.
The company has advised patients taking Quinapril Tablets USP, 20mg, and 40mg, to continue the medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.
In the last three sessions, Lupin shares rose 6% after the company announced that it has received U.S. FDA approval for its Abbreviated New Drug Application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. Brivaracetam is used in the treatment of partial onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age and older. The drug works by decreasing abnormal electrical activity in the brain.