cGMPs / Packaging

Merck Recalls Liptruzet Cholesterol Drug Due to Packaging Defects

Jan 15, 2014

Merck

Merck is voluntarily recalling all lots of Liptruzet (ezetimibe and atorvastatin) 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg tablets in the United States, including Puerto Rico, due to packaging defects.

Merck is recalling from wholesalers all lots of Liptruzet that have been distributed since the product was introduced in May 2013. The medicine is not being recalled from patients or pharmacies.

Some of the outer laminate foil pouches may allow in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. According to the company, 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. 

The recall will deplete all available supply in the U.S., and stock-outs are expected.

Read the Merck press release