On Friday, November 19, 2010, Johnson & Johnson and Millennium Pharmaceuticals recalled thousands of vials of Velcade in the United States, Europe, Malaysia, and Japan, after the two companies received numerous reports of white particles floating in the vials.
The vials that were recalled were distributed between January and June of 2010 and according to Reuters, the particles have been identified as a polyester-like material related to a component of the manufacturing process performed by a contract manufacturer for Millennium, which is now a unit of Japan's Takeda Pharmaceutical Co.
Velcade, also known as bortezomib, is a drug designed to treat cancer patients suffering from multiple myeloma and mantle cell lymphoma. It works by interfering with the growth of some cancer cells and stops them from spreading.
According to Google Health, multiple myeloma is a cancer of the plasma cells in bone marrow, while mantle cell lymphoma is an uncommon type of non-Hodgkin's lymphoma.
To date, seven lots have been recalled in the United States, six lots in Europe, and six lots in Japan. "In the U.S. we have received no confirmed product complaints or adverse events related to this issue," Millennium spokeswoman Manisha Pai said.
In Europe, the recalled lots originally included about 195,000 vials of the 3.5 milligram dose of Velcade, but J&J expects to see only a fraction of that returned. "Based on what we know, the majority of the lots has already been consumed. We anticipate recapturing about 20,000 vials," J&J spokeswoman Kellie McLaughlin said. "The same is true for the United States," says Pai.
The cause of the problem stems from a deficiency in the manufacturing process, which both companies have claimed to have fixed since the recall.


