The drug company is recalling from wholesalers all lots of Liptruzet distributed since the product was introduced in last May because the packaging defects could reduce the medication's effectiveness.
Some of the outer laminate foil pouches might allow in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the combination cholesterol drug, Merck said.
The likelihood of the packaging defect decreasing the effectiveness of the drug on a patient's lipid profile or negatively impacting the safety of the product is remote, Merck said. The decision to recall Liptruzet was not based on any reported adverse experiences or product quality complaints, Merck said.
Merck said it was working with the U.S. Food and Drug Administration on this recall and is informing U.S. wholesalers. The medicine is not being recalled from patients or pharmacies.
"Patients may continue taking Liptruzet in their possession as prescribed by their healthcare provider," Merck said in a statement.
"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."
Patients who have questions are encouraged to talk to their healthcare provider, and to not stop therapy without first speaking with their physician. Merck is committed to resupplying Liptruzet as soon as possible."
The recall does not affect any other products manufactured by Merck.