Particle contamination in vials of the blood-cancer drug Velcade are driving a recall that touches North America, Europe and Asia. The precautionary action follows five reports of post-reconstitution visible particles, reports Bloomberg.
A fix to the "manufacturing problem" is already in the works, according to Takeda, whose Millennium Pharmaceuticals group co-markets the drug with Johnson & Johnson's ($JNJ) Janssen-Cilag unit. The contaminant is a "white polyester-like material that stemmed from a filtration system," reports PBR Regulatory Affairs.
The particles were found in vials from two batches made for Millennium by a contract manufacturer. Janssen-Cilag is recalling all remaining stock of six batches distributed between January and June this year.
Velcade is co-developed by Millennium and J&J's Ortho Biotech Oncology Research & Development unit. Millennium has commercialization rights in the U.S.; Janssen-Cilag, in Europe and the rest of the world. No adverse events have been reported.
- see the article
- here's the Bloomberg report