Merck ($MRK) is recalling all the lots of its cholesterol drug Liptruzet distributed since its approval in the U.S. last May, saying that packaging problems could affect its potency. It has warned the FDA that shortages are expected from the voluntary recall.
"The recall will deplete all available supply in the U.S., and stock-outs are expected. The two active ingredients remain available: Zetia (ezetimibe), from Merck, and atorvastatin is available as a generic from multiple manufacturers," Merck said in a statement Tuesday.
The voluntary recall is to the wholesale level and involves everything shipped in the U.S. and Puerto Rico. The company said that the outer laminate foil on some of the pouches may allow in air and moisture that has the potential to impair the effectiveness or change the characteristics of the product. It said there is only a "remote" likelihood of the manufacturing defect affecting the safety of the drug or leading to any effect on a patient's lipid profile, and that there have not been any reports of patients experiencing problems. In fact, Merck said patients with drugs on hand should feel safe using them.
The recall comes about three weeks after the Centers for Disease Control and Prevention (CDC) reported that Merck had recalled one lot of its Gardasil HPV vaccine because of a chance that a small number of vials had glass particles in them. Merck said only about 10 of 743,360 vials were suspect. Just last week, Roche ($RHHBY) warned there could be spot shortages of the oral formulation of its Tamiflu vaccine because a surge in demand was leading to packaging delays at a Genentech facility.
The new cholesterol combo melds Merck's Zetia drug with generic Lipitor. When Merck announced the approval, it pointed out that Liptruzet lowered patients' cholesterol levels in trials better than generic Lipitor alone, but also acknowledged that the drug didn't actually reduce trial participants' chances of developing heart disease.
- here's the release