Merck, known as MSD outside the United States and Canada, 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, the company announced in a press release. The recall affects wholesalers but not patients or pharmacies. Stock-outs are expected, but Merck is committed to resupplying Liptruzet as soon as possible.
Merck is recalling from wholesalers all lots of Liptruzet that have been distributed since the product was introduced in May 2013. 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. 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 decision to recall Liptruzet was not based on any reported adverse experiences or product quality complaints.
The recall will deplete all available supply in the US. The two active ingredients remain available: Zetia (ezetimibe) is available from Merck, and atorvastatin is available as a generic from multiple manufacturers. The recall does not affect any other products manufactured by Merck.