Medscape... WHITEHOUSE STATION, NJ — All lots of the cholesterol drug marketed as Liptruzet (ezetimibe and atorvastatin) across four doses are being recalled, the manufacturer, Merck, announced today[1]. The recall affects tablets in the 10/10-mg, 10/20-mg, 10/40-mg, and 10/80-mg dosages, sold to wholesalers in the US and Puerto Rico and will deplete all available stock of the product in the regions.
According to a Merck press release, the recall stems from packaging defects such that "the outer laminate foil pouches may allow in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product."
No adverse experiences or product-quality complaints have been reported, the release notes, and 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 two drugs that make up the combination product are still available: ezetimibe (Zetia) from Merck and atorvastatin as a generic sold by multiple manufacturers, the release notes.
"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 fax (1-800-FDA-0178), or regular mail using the postage paid, preaddressed form available at: www.fda.gov/MedWatch/getforms.htm.