Sanofi's ($SNY) biotech unit Genzyme is recalling more than 36,000 vials of its thyroid cancer drug Thyrogen from the U.S., Puerto Rico and four other countries. Thyrogen is one of a several drugs that had been in short supply some years back after Genzyme ran into manufacturing issues.
According to the most recent FDA Enforcement Report, Sanofi Genzyme is recalling 4,669 cartons of Thyrogen that contain two vials each as well as another 27,022 single vials after glass particles were found in the in some of the drugs when they were reconstituted. In addition to the U.S. and Puerto Rico, Sanofi Genzyme is recalling the contaminated vials from Malaysia, Taiwan, Brazil, and Israel.
In an emailed statement, a Genzyme spokesperson said: "Sanofi Genzyme is fully committed to maintaining the highest product quality standards. This recall is unrelated to previous manufacturing issues and we do not anticipate any supply issues at this time."
Genzyme restored supplies of Thyrogen to the market in 2012 after about three years, during which supplies were inconsistent. Problems arose in 2009, when viral contamination was found at a Genzyme plant in Allston, MA, where Genzyme manufactured the rare disease drug Fabrazyme and Gaucher disease drug Cerezyme and where the fill/finish work was done on Thyrogen.
The quality problems led to investor dissatisfaction for Genzyme. As it scrambled to clean up the facility, it drew buyout interest from Sanofi, which promised that its manufacturing expertise was what Genzyme needed. That led to a $20.1 billion deal and the move to build a new plant in Framingham, MA, to resolve the shortage issues. The plant opened in 2012 and the next year Sanofi said it would invest another $80 million to expand the facility as sales of Fabrazyme soared.
- read the recall here and here