"Cholesterol Medication Recall: 6,500 Containers Pulled Nationwide"

Concerns Regarding High Cholesterol in America

High cholesterol is a prevalent issue in the United States, with health experts estimating that only 54.5% of adults who could benefit from cholesterol medications are actually taking them. This equates to approximately 47 million individuals who may not be effectively managing their cholesterol levels.

Recall of a Commonly Used Cholesterol Medication

Individuals who are already prescribed medication to control their cholesterol levels should take note of a recent recall affecting a commonly used option. The U.S. Food and Drug Administration (FDA) announced the recall of an estimated 6,759 containers of Ezetimibe and Simvastatin Tablets, both nationwide in the U.S. and in Puerto Rico.

About Ezetimibe and Simvastatin

According to the Mayo Clinic, Ezetimibe and Simvastatin are often used together to treat high cholesterol. Ezetimibe works by limiting cholesterol absorption, while Simvastatin, a statin, blocks an enzyme to reduce cholesterol levels. This medication is commonly known by the brand name Vytorin.

Details of the Recall

The recalling firm, Glenmark Pharmaceuticals Inc., USA, was previously involved in a recall earlier this year for different types of cholesterol medications. The latest recall is due to "Failed Impurities/Degradation Specifications," specifically related to Anhydro Simvastatin during a long-term stability study.

• Ezetimibe and Simvastatin Tablets, 10mg/40mg
• 90-count bottle, Rx only
• Lot #: 17240195
• Expiration Date: 01/31/2026
• Manufactured by: Glenmark Pharmaceuticals Ltd., India
• Manufactured for: Glenmark Pharmaceuticals Inc., USA
• National Drug Code (NDC): 68462-323-90
• Product quantity: 6,759 containers - 90 bottle pack

Class III Recall

Although the recall was initiated in May, the FDA classified it as a Class III recall on June 10. Class III recalls involve products that are not likely to cause health issues but do not meet FDA regulations regarding labeling or manufacturing.

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