Home / Health / Novartis Recalls Diovan: Quality Flaw Cited
Novartis Recalls Diovan: Quality Flaw Cited
12 Aug
Summary
- Novartis voluntarily recalled its blood pressure drug Diovan on August 4.
- The recall is due to failed dissolution specifications, possibly affecting absorption.
- The FDA classified the recall as a Class II event, indicating moderate risk.
Novartis initiated a voluntary recall on August 4 for its brand-name blood pressure medication, Diovan. The U.S. Food and Drug Administration (FDA) announced this recall on August 8.
Diovan, a brand of valsartan, is used to treat high blood pressure and heart failure. The reason for the recall is "Failed Dissolution Specifications," indicating a potential issue with how the drug dissolves for absorption.
The FDA categorized the recall as a Class II event on August 7. This classification suggests that while the drug's use could lead to temporary or medically reversible adverse health consequences, the probability of serious health issues is considered remote.
The affected Diovan medication was reportedly manufactured by Patheon Manufacturing Services in North Carolina and distributed by Novartis's New Jersey office. The FDA's classification reflects a mid-tier severity level for the recall.
