When a prescription drug is recalled, often it’s a generic version that’s being pulled from market. But this time, it’s a name-brand blood pressure drug by a pharmaceutical company with its own recognizable name.
In a report sent out Saturday, August 8, the U.S. Food and Drug Administration (FDA) announced that Novartis had voluntarily initiated an August 4 recall on Diovan, the company’s brand of valsartan, which the Mayo Clinic explains is an angiotensin II receptor blocker, “blocking a substance in the body that causes blood vessels to tighten.”
The Mayo Clinic adds: “Valsartan is used alone or together with other medicines to treat high blood pressure (hypertension) … Valsartan is also used to treat heart failure and left ventricular failure after a heart attack.”
The FDA report states that the recall is due to “Failed Dissolution Specifications,” a quality flaw which could possibly mean that testing revealed the drug doesn’t dissolve as indicated for bodily absorption.
How to tell if your prescription is affected
The FDA provided the following details in its report:
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Diovan (valsartan) 160 mg (milligrams)
The drug was reportedly manufactured by North Carolina-based Patheon Manufacturing Services and distributed by Norvartis’s New Jersey office.
What’s the overall risk?
The FDA was quick to determine a risk level for the Diovan recall, naming it a Class II event on Friday, August 7. This is the FDA’s mid-tier severity level, which they define as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
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