Whitehouse Station, NJ, US-based Merck is voluntarily recalling all lots of Liptruzet (ezetimibe and atorvastatin) in the US, including Puerto Rico, because of packaging defects that could reduce the effectiveness of the cholesterol drug.
Merck is recalling from wholesalers all four doses of Liptruzet, including 10/10mg, 10/20mg, 10/40mg and 10/80mg tablets, which have been distributed since the product was introduced in May 2013.
The firm says some of the outer laminate foil pouches may allow in air and moisture, which could potentially reduce the effectiveness or change the characteristics of the product, but adds that the recall is not based on any reports of adverse experiences or complaints about product quality.
The recall will clear out all of the stock of Liptruzet in the US, although the two active ingredients remain available: Zetia (ezetimibe), from Merck, and atorvastatin is available as a generic from multiple manufacturers.
Merck says it is working with the US Food and Drug Administration (FDA) on this recall and was informing wholesalers across the US.
The medicine is not being recalled from patients or pharmacies and patients who already have the drug can continue taking it.
Merck says it aims to replenish stocks 'as soon as possible'.
