Four batches of the hypertension medication Quinapril sold by Lupine Pharmaceuticals are being recalled due to nitrosamine impurity, the company announced last week in a voluntary recall on the U.S. Food and Drug Administration website. Nitrosamines are organic compounds found in low concentrations in food and water. But at higher levels and with regular exposure over a long period of time, they can increase the risk of cancer.
Lupine is recalling four batches of Quinapril tablets because recent testing has shown them to exceed the acceptable daily intake (ADI) for nitrosamines. In the past few years, the FDA has expanded its guidelines for controlling nitrosamine impurities in some commonly used drugs, including blood pressure and diabetes medications, likely leading to more testing by drug companies. Blood pressure medications made by Aurobindo and Pfizer were voluntarily recalled earlier this year due to the same nitrosamine problem.
To date, no illness reports have been reported to Lupine, the recall said, and the company stopped marketing 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 September 1, 2022. You can the specific lot or UPC numbers to see if your medication is included in the recall.
Patients currently taking the recalled lots are “advised to continue taking their medications and to contact their pharmacist, physician or medical provider for advice on alternative treatment,” Lupine said. Quinapril is used to treat hypertension by lowering blood pressure. It’s important to treat high blood pressure, as it can increase your risk of serious health problems, including stroke and heart disease. Heart disease was the leading cause of death in 2021.
The label for Lupin’s Quinapril Tablets. Only three lots or batches of the 40 mg tablets are included in the recall. The recalled 20 mg label looks similar but is blue in color and has “20 mg” printed on it.
Lupine Pharmaceuticals through the US Food and Drug Administration
In a reminder, Lupine said consumers or distributors of the medication can contact Inmar Rx Solutions with questions at 877-538-8445, Monday through Friday, 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 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 care professional if you have any questions about a medical condition or health goals.