Cubist Pharmaceuticals ($CBST) has again been tripped up by one of its contractors, having to recall a single lot of its injectable antibiotic Cubicin because of particulate. The recall comes 8 months after a similar problem led it to recall four lots of the drug.
The Lexington, MA-based drugmaker voluntarily initiated the recall after a customer complaint of particulate, which it said it identified as glass. It has tracked the problem back to a single lot of the drug made by one of it suppliers and said "Cubist has suspended all manufacturing on this line." So far there have been no complaints of adverse events tied to the affected lot.
The company did not say if the lot was produced by the same contractor that was tied to the recall last August of four lots of Cubicin. That was also because of glass particulate. At the time, Cubist said it would make sure the problem was fixed before resuming production with the supplier.
It is not uncommon to have recalls tied to glass particulate in vials. Ranbaxy, Hospira ($HSP) GlaxoSmithKline ($GSK), and Fresenius Kabi recalled products last year because of glass particulates.
Cubist expects U.S. sales of Cubicin to well exceed $1 billion by the end of 2017. But it has a host of other antibiotics under development. In fact, last month, the FDA's Anti-Infective Drugs Advisory Committee voted 14-0 to recommend approval of tedizolid phosphate to treat acute bacterial skin infections, which are caused by drug-resistant pathogens including MRSA. Assuming approval, the will be sold under the brand Sivextro. It can be administered either orally or intravenously.
- here's the Cubicin recall notice