A contractor has tripped up Shire ($SHPG), which is voluntarily recalling three lots of its Gaucher drug Vpriv after finding stainless steel particulate in a small number of vials of the injected drug. The drugmaker said the problem was traced to the company handling the fill finish for Shire.
The Ireland-based drugmaker said the three lots were from a single batch. It voluntarily undertook the recall after the stainless steel and barium sulfate particulate was discovered. No adverse effects have been reported, but in an announcement on Friday Shire cautioned there are risks to anyone injected with the particulate.
The company emphasized that it "has significant quantities of Vpriv to replace any affected product" and does not expect a supply disruption stemming from the recall. Shire has promoted its drug's availability as an indirect selling point against a rival product, Cerezyme, from Genzyme that ran into supply issues when viral contamination forced the closure of a facility in 2009.
Gaucher disease is a painful inherited condition affecting fewer than 10,000 people in the U.S. The supply interruptions of Cerezyme went on for several years, creating some ill will against Genzyme from Gaucher patients unable to get the drug. Now owned by Sanofi ($SNY), Genzyme resolved those problems in 2012 with construction of a new plant--but Shire never misses an opportunity to allude to the issue. When the FDA approved Shire's plant in Lexington, MA, last month as a second U.S. site for making Vpriv, it said: "Shire has always been committed to providing uninterrupted treatment for all Vpriv patients."
- here's the recall announcement