The combination cholesterol drug Liptruzet will be unavailable in the US for the foreseeable future, says Merck & Co., after packaging defect at CMO led to a total product recall.
The voluntary recall of the drug was initiated yesterday due to a packaging defect at Merck’s contract manufacturing partner, and effects all lots distributed in the US and Puerto Rico since the product was launched in May 2013.
According to Merck (known as MSD outside North America), the problem was due to the outer laminate foil pouches which could potentially let in moisture, though the firm added the defect was unlikely to decrease the effectiveness of the drug or negatively impact the safety of the patient.
Spokesperson Pam Eisele told in-Pharmatechnologist.com that “an evaluation of corrective actions was underway,” at the contract manufacturer but specific details were not divulged.
However, she did tell us a “stockout is anticipated as the product would not be available for the foreseeable future.”
Though this in effect could indicate a shortage, the drug itself is a combination product comprised of two active ingredients, both unaffected by the recall
The first is Merck’s own cholesterol drug Zetia (ezetimibe) which remains available, whilst the second is atorvastatin - a generic version of Pfizer’s Lipitor which lost its exclusivity in November 2011 - and available from a number of manufacturers.
The company has initiated the recall with the US Food and Drug Administration (FDA) and is directed at wholesalers rather than patients and pharmacies themselves, adding patients should continue taking Liptruzet in their possession as advised.