No adverse events have been reported to date in association with a product complaint of vials containing glass particulates, according to the FDA.
“An internal investigation by Cubist has preliminarily identified the root cause as a manufacturing issue with a single production line at one of Cubist’s third party Cubicin drug product manufacturers,” Julie DiCarlo, a spokeswoman for Cubist told Outsourcing-Pharma.
“Cubist has suspended all manufacturing with the supplier until corrective and preventative measures have been taken” she added, going on to say that the firm “does not expect that this recall will interfere with the ongoing supply of Cubicin” because “we have another supplier that is not impacted."
CMO
Cubist did not name the contract manufacturing organisation (CMO) involved when asked by Outsourcing-pharma.com.
According to documents filed with the US Securities and Exchange (SEC) commission at least two third-party manufacturers have been involved in producing Cubicin on Cubist's behalf.
In an 8-K filed in June 2008, Cubist announced that Hospira would continue to provide fill/finish services for Cubicin (daptomycin for injection). An amendment the companies’ previous agreement also called for the validation of a second facility where Hospira will be able to provide fill/finish, as well as other services.
Hospira spokesman Dan Rosenberg told Outsourcing-Pharma.com, “As a general practice, we do not comment on our customers or the products we manufacture for them on the contract manufacturing side of the business.”
Cubist also has a manufacturing agreement with Italy-based ACS Dobfar SpA that dates back to September 2001 according to a 10-K filed on February 27, 2009. The filing names ACS as the sole commercial supplier of the Cubicin active pharmaceutical ingredient (API).
ACS did not respond to a request for comment by press time.
Ongoing investigation
“Our investigation into the exact cause of the issue is ongoing, but we can say it does not appear to be systemic only a select number of vials in the recalled lots appeared to be impacted,” DiCarlo added.
That investigation will be important for Cubist as the injection is the company’s flagship product and net sales climbed 13.4% in the US to $227.1 million in Q2 of 2013.