It also treats heart conditions but is the latest in a string of drugs treating these conditions that’s being flagged for quality concerns.
In the past year, multiple hypertension medications have been recalled due to the suspected development of chemical compounds, called nitrosamines, that are linked with cancer. The compounds can occur inadvertently over time or due to environmental and other conditions.
In a Food and Drug Administration (FDA) report published last week comes the latest blood pressure medication recall. A May 5 FDA notice revealed that on April 23, Unique Pharmaceutical Laboratories (a division of JB Chemicals and Pharmaceuticals Ltd) in India recalled 675 bottles of Enalapril Maleate Tablets in 1,000-count bottles, containing 20-milligram dosages. The product was then distributed by New Jersey-based Rising Pharma Holdings, Inc.
The FDA says the recall on this ACE inhibitor, indicated for hypertension and heart failure, covers distribution “Nationwide in the USA” after a possible quality issue was discovered, reportedly through routine testing.
The FDA states the following as the finding that triggered the event: “Failed Impurities/Degradation Specifications: Out of specification result occurred in Organic Impurities Test.” Given the broader regulatory environment around nitrosamine impurities in ACE inhibitors in recent years, that would seem a reasonable line of inquiry—though in this case it’s not confirmed that the issue is related to nitrosamine or any other cancer-associated issue.
Affected product can be identified by lot number GEH25023 and expiration 6/30/2027. The medication also has a National Drug Code (NDC) of 64980-688-10.
The May 5 update indicates that the FDA has given the recall a Class II designation, defined as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.”
While the specific impurity or degradation issue hasn’t been publicly communicated, it’s typically not advisable to stop taking a heart-related medication without speaking with a doctor or pharmacist first.
Written by Kristine Gasbarre Qaderi for The Healthy ~ May 11, 2016