Recent testing revealed levels of a nitrosamine impurity (N-nitroso-quinapril) were above the U.S. Food and Drug Administration’s (FDA) acceptable daily intake level. While long-term ingestion of this suspected carcinogen may increase cancer risk, there is no immediate danger to patients taking this medication. According to an announcement from the FDA issued on December 21, the quinapril products in question are:
20 mg tablets, lot number G102929, expiration date 04/202340 mg tablets, lot number G100533, expiration date 12/202240 mg tablets, lot number G100534, expiration date 12/202240 mg tablets, lot number G203071, expiration date 03/2024
The pills were packaged in 90-count bottles and distributed nationwide to wholesalers, drug chains, mail order pharmacies, and supermarkets between March 15, 2021 and September 1, 2022. Although Lupin discontinued these quinapril tablets in September, wholesalers, distributors, and retailers may still have the products and are urged to discontinue distribution of the recalled lots immediately.
What Is Quinapril Used for?
Quinapril treats high blood pressure and belongs to a class of drugs called angiotensin-converting enzyme (ACE) inhibitors. It’s prescribed for lowering blood pressure, which reduces the risk of fatal and nonfatal cardiovascular events like strokes and heart attacks. People who have been using the affected quinapril lots should speak to their healthcare provider about alternative treatment options.
What Are Nitrosamines?
Nitrosamines are common chemicals that naturally exist in low amounts in water and foods, including cured and grilled meats, dairy, and even vegetables. Everyone is exposed to some level of nitrosamines. They can increase the risk of cancer, though, if an individual is exposed to them above acceptable levels over long periods of time. The FDA notes that a person taking a drug that contains nitrosamines at or below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.
Quinapril Has Been Recalled Multiple Times
This isn’t the first time high blood pressure medications have been recalled due to high amounts of nitrosamine. In April 2022, for example, Pfizer removed five lots of Accupril (quinapril HCl) tablets. In October, Aurobindo Pharma USA recalled two lots of quinapril-hydrochlorothiazide tablets. Anyone with questions regarding this latest recall should contact Inmar Rx Solutions at 877-538-8445, Monday to Friday, 9 a.m. to 5 p.m. EST. For reimbursement, consumers will need to provide the lot number, which can be found on the side of the bottle label.
