Johnson & Johnson and Takeda units recall batches of Velcade on reports of impurities

Recalls of the cancer- fighting drug touch on Europe, the United States, Japan and Malaysia and involve batches of the drug distributed between January and June 2010

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NEW BRUNSWICK, N.J., and CAMBRIDGE, Mass—Johnson & Johnson and Millennium Pharmaceuticals have recalled thousands of vials of the cancer drug Velcade (bortezomib) sold in Europe, the United States, Japan and Malaysia after reports of white particles floating in batches of the medicine distributed between January and June of this year.

Velcade, known chemically as bortezomib, is approved to treat multiple myeloma and relapsed mantle cell lymphoma. It is sold in the United States by Millennium, which is a unit of Japanese company Takeda Pharmaceutical Co. and by Janssen-Cilag, a unit of Johnson & Johnson, in Europe and the rest of the world.

As unwanted as the recall might be for Millennium and its parent company, the news is probably less palatable to Johnson & Johnson, which has already had to deal with massive recalls of many over-the-counter consumer health products, including Children's Tylenol and Motrin—a total of some 40 medicines in the past year.

The particles in the Velcade batches have been identified as a polyester-like material that is associated with a component of the manufacturing process that is performed by a contract manufacturer for Millennium. The manufacturing problem linked with the presence of the particles is being corrected, according to Seizo Masuda, a spokesperson for Takeda in Tokyo.

Some 200,000 vials were produced in the affected lots for the United States, and almost that many in Europe, but the vast majority of those vials have already been administered to patients, so Johnson & Johnson expects to recover only 20,000 vials, and Millennium anticipates recapturing roughly half that number. As yet, there have been no confirmed reports of adverse events related to use of the affected vials, and the companies are calling the recall effort a "precautionary measure."
 


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