Glass particles have struck again, this time contaminating four lots of the injectable antibiotic Cubicin and triggering a recall from its producer, Cubist Pharmaceuticals ($CBST).
According to an FDA report, an internal investigation has tabbed the root cause as a manufacturing issue with an unnamed supplier. Cubist has called off all manufacturing with that supplier, and the Lexington, MA-based pharma won't resume production there until the supplier fixes problems and installs preventative measures. So far, the company has not received complaints related to the particles, the report says.
As the FDA notes, glass particles can pose serious safety risks when present in an IV drug. And they've also spurred several recalls as of late. Ranbaxy, Hospira ($HSP) and GlaxoSmithKline ($GSK) have all found glass particles in their products this year; most recently, Fresenius Kabi conducted its second 2013 recall on account of glass particles.
Cubist is expecting big things from Cubicin, an antibiotic targeted at hard-to-treat skin and bloodstream infections. Last summer, as it laid out its 5-year growth plan, the company announced a $2 billion sales goal that had Cubicin at the heart of things. Cubist said it was looking to U.S. sales of the drug to well exceed $1 billion by the end of 2017.
- see the FDA's report