Four batches of the hypertension medication Quinapril sold by Lupin Pharmaceuticals are being recalled over nitrosamine impurity, the company announced last week in a voluntary recall posted to the US Food and Drug Administration’s website. Nitrosamines are organic compounds found in food and water at low levels. But at higher levels, and with regular exposure over a long period of time, they may increase the risk of cancer.
Lupin is recalling four lots of Quinapril tablets because recent testing found they exceed the acceptable daily intake (ADI) level for nitrosamines. Over the last couple of years, the FDA has added to its guidance for controlling nitrosamine impurities in some common drugs, including blood pressure and diabetes medication, likely leading to more testing by pharmaceutical companies. Blood pressure medications made by Aurobindo and Pfizer were voluntarily recalled earlier this year over the same nitrosamine concern.
To date, no reports of illness have been reported to Lupin, the recall said, and the company discontinued marketing of its Quinapril tablets in September.
The four lots included in the recall were sold as 20 mg or 40 mg tablets and have expiration dates through April 2023, December 2022 and March 2024. They were distributed from March 15, 2021, through Sept. 1, 2022. You can check the specific lot or UPC numbers to see if your medication is included in the recall.
Patients currently taking the recalled batches are “advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment,” Lupin said. Quinapril is taken to treat hypertension by lowering blood pressure. It’s important to treat high blood pressure because it can increase your risk for serious health problems, including stroke and heart disease. Heart disease was the leading cause of death in 2021.
Lupin said in the recall that consumers or distributors of the medication can contact Inmar Rx Solutions with questions at 877-538-8445, Monday through Friday from 9 a.m. to 5 p.m. ET. It also said the recalled lots can be returned to Inmar for reimbursement.
Read more: The Wave of Recalls, Explained
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.