Merck & Co. is voluntarily recalling all lots of Liptruzet tablets, a cholesterol-lowering medication, in the United States (including Puerto Rico) and Canada because of packaging defects.


Merck, Liptruzet, recall, packaging defects, ezetimibe and atorvastatin, cholesterol-lowering medication






































































































































































































































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Merck issues recall of Liptruzet

January 14th, 2014

WHITEHOUSE STATION, N.J. – Merck & Co. is voluntarily recalling all lots of Liptruzet tablets, a cholesterol-lowering medication, in the United States (including Puerto Rico) and Canada because of packaging defects.

The drug maker said Tuesday that it's recalling from wholesalers all lots of Liptruzet (ezetimibe and atorvastatin, in 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg tablets) that have been distributed since the product was introduced last May.

Merck noted that the medication isn't being recalled from pharmacies or patients and that the company is working with the Food and Drug Administration on the recall.

According to Merck, some of the product's outer laminate foil pouches may allow in air and moisture, which could lower the effectiveness or change the characteristics of the medicine. The company noted, however, that the likelihood of the packaging defects decreasing the effectiveness of Liptruzet on a patient’s lipid profile or negatively impacting the safety of the product is remote.

In addition, Merck said it expects Liptruzet out-of-stocks because the recall will deplete all available supply in the United States. The two active ingredients remain available: Zetia (ezetimibe) from Merck, and atorvastatin as a generic from multiple manufacturers.

"Merck is committed to resupplying Liptruzet as soon as possible," the company stated.

Liptruzet is indicated to lower LDL cholesterol, or "bad" cholesterol, by helping to block the absorption of cholesterol that comes from food and reducing the cholesterol that the body makes naturally based on family history. According to Merck, the product also can help lower total cholesterol and triglycerides, as well as raise the levels of HDL cholesterol, or "good" cholesterol.

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