Merck Issues Voluntary Recall Of LIPTRUZET™ In The US Due To Packaging Defects
Healthcare leader Merck has asked for a voluntary recall of all lots of LIPTRUZET™ (ezetimibe and atorvastatin) due to packaging defects that could affect effectiveness of the product. The recall concerns all wholesale lots of Liptruzet sold across the United States including Puerto Rico beginning last May 2013.
Liptruzet is used to lower cholesterol in patients. The drug is sold in 10/10 mg, 10/20 mg, 10/40 mg, and 10/mg tablet variants in the US.
The large-scale recall was due to possible malfunction of the outer laminate of the drug packaging. Merck said some of the outer laminate foil pouches may allow in moisture and air, possibly leading to changes in the characteristics of the product or decrease in its effectiveness. Even in such a packaging malfunction event, Merck said the likelihood of negatively impacting the product safety or reducing Liptruzet’s effectiveness on patients’ lipid profile was remote.
The company stated that the recall was not due to any product quality complaints or reports of adverse experience. Patients who are already using the drug in their possession may continue to do so as prescribed by doctors and healthcare providers. The recall similarly does not affect pharmacies that have the drug in their possession. Merck is reportedly working with the U.S. Food and Drug Administration (FDA) to inform and recall the drug from wholesalers. Patients with adverse reactions from use of affected Liptruzet may report to the FDA’s MedWatch Adverse Event Reporting program.
Liptruzet’s recall will cause all available U.S. supply to decline. Though stock-outs are expected to occur, Liptruzet’s two active ingredients may still be obtained. ZETIA® (ezetimibe) is supplied by Merck, while atorvastatin remains available as a generic from several manufacturers.
Merck said Liptruzet’s recall does not affect its other products. The company is working to resupply the drug as soon as possible.
Source:
http://www.mercknewsroom.com/news/company-statements/merck-voluntarily-recalls-all-lots-liptruzet-united-states-wholesalers-due-0