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Thousands of Vials of Cancer Drug Velcade Recalled

The popular injectable drug Velcade or Bortezomib is used primarily to treat patients with bone marrow cancer as well as mantle cell lymphoma. Velcade has been the subject of controversy for some time due to its high cost and brutal side effects. But the problems for Velcade took a turn for the worse this week when Johnson & Johnson and Millennium Pharmaceuticals recalled thousands of vials of the drug sold in the United States, Japan, Europe and Malaysia. The recall was spurred after the companies received reports of white particles seen floating in vials of the medication. A polyester-like material was found in batches of the drug distributed between January and June of this year. The particles are thought to be related to a component in the production process performed by a contract manufacturer for Millennium, a subsidiary of Takeda Pharmaceutical Co. Six lots were voluntarily recalled in Europe and Japan following five reports of floating particles found in samples from the recalled lots. As a precautionary measure, an additional seven lots were pulled off the market in the United States. Worldwide, an estimated 300,000 vials are believed to contain the particles, but officials at Johnson & Johnson believe only a fraction of those vials will be returned. There have been no reports of injuries or reactions caused by recalled lots of Velcade thus far. Velcade has been on the Food and Drug Administration's radar since earlier this year when the agency, in cooperation with Millennium, warned doctors to monitor the dosages of the drug given to their patients. Velcade has been known to increase the likelihood of liver damage in people suffering from mild to serious liver conditions. The product joins the ever-growing list of Johnson & Johnson medications that have been recalled. Children's Tylenol and Motrin, as well as dozens of other J&J products, have been pulled off of store shelves since earlier this year.

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