Merck Voluntarily Recalls All Lots of LIPTRUZET in the US From Wholesalers Due to Packaging Defects

Merck, known as MSD outside the US 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 US, 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. 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, and stock-outs are expected. The two active ingredients remain available:  ZETIA (ezetimibe), from Merck, and atorvastatin is available as a generic from multiple manufacturers. The recall does not affect any other products manufactured by Merck.

Merck is working with FDA on this recall. Merck is informing wholesalers in the US. The medicine is not being recalled from patients or pharmacies. Patients may continue taking LIPTRUZET in their possession as prescribed by their health care provider. Patients who have questions are encouraged to talk to their health care provider, and to not stop therapy without first speaking with their physician. Merck is committed to resupplying LIPTRUZET as soon as possible.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.