Less than a year after it received FDA approval for its combo cholesterol drug, Merck reported it was recalling tablets due to packaging defects.
The FDA approved ezetimibe and atorvastatin (Liptruzet) in May 2013 for treatment of elevated levels of low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia. Merck announced that it was recalling 10/10 mg, 10/20 mg, 10/40 mg and 10/80 mg tablets that were distributed after approval because flaws in packaging may expose the tablets to air and moisture and possibly decrease the drug’s effectiveness.
Merck, based in Whitehouse Station, N.J., said it had not received any complaints or reports of adverse consequences. It had contacted wholesalers about the recall; patients and providers do not need to discontinue use although supplies will be depleted. The two active ingredients—ezetimibe (Zetia) and atorvastatin— are available in generic form.