A blood pressure medication has been recalled nationwide over concerns the drug may not break down properly in the body, health officials said.
In an Aug. 7
notice, the U.S. Food and Drug Administration (FDA) said Novartis Pharmaceuticals Corporation had issued a recall for its Diovan in 160-milligram, 90-tablet bottles.
The agency said the affected lot was pulled for "failed dissolution specifications,"
indicating the tablets did not meet the required standard for how quickly and how much of the drug's active ingredient dissolved during testing.
Diovan is a brand-name version of the prescription blood pressure medication valsartan. According to the Mayo Clinic, valsartan is commonly used to
treat hypertension, or high blood pressure, as well as heart failure and left ventricular failure following a heart attack. The drug works by blocking a substance called angiotensin II that narrows blood vessels, allowing the vessels to relax and lowering blood pressure.
The FDA classified the recall as
Class II, meaning the use of the product "may cause temporary or medically reversible" health problems, while the risk of serious adverse health consequences is considered remote.
The recall applies to lot AV5913C, which has an expiration date of June 2027. The medication was manufactured by Patheon Manufacturing Services LLC and distributed by Novartis Pharmaceutical Corp.
The FDA did not indicate how many bottles of Diovan are included in the recall. NTD reached out to Novartis for more information, but a response was not received by publication time.
Thousands of bottles of blood pressure medication were recalled earlier this year for also failing to meet dissolution specifications.
Inventia Healthcare Limited recalled 11,460 bottles of 25-milligram chlorthalidone tablets on June 5, per an FDA
notice. The Class II recall included 100-tablet bottles from lot RISA24001 and 1,000-tablet bottles from batch RISB24002, both with an expiration date of April 2027.
Months earlier, in March, the FDA
announced that Appco Pharma LLC had pulled more than 175,000 bottles of prazosin hydrochloride capsules nationwide after testing detected a potentially cancer-causing nitrosamine compound called N-nitroso-prazosin impurity C at levels that were "above acceptable limits."
More than a dozen lots were included in the Class II recall, covering 100-count bottles of 1-, 2-, and 5-milligram capsules.
Prazosin hydrochloride belongs to a class of medications known as
alpha-blockers and is also used to treat hypertension. When left untreated, high blood pressure can damage blood vessels, along with the brain, heart, kidneys, and other organs, potentially leading to serious health issues, including heart disease, heart failure, stroke, and kidney failure.
