UPDATE 1-J&J, Takeda recall batches of cancer drug Velcade

by Reuters
Thursday, 18 November 2010 22:11 GMT

* White particles found floating in vials of the drug

* Recall in Europe, Japan, U.S. and Malaysia

* No injuries or new safety issues identified (Adds Millennium comment, U.S. voluntary recall)

By Bill Berkrot

NEW YORK, Nov 18 (Reuters) - Johnson & Johnson <JNJ.N> and Millennium Pharmaceuticals are recalling thousands of vials of the cancer drug Velcade sold in Europe, the United States, Japan and Malaysia after receiving reports of white particles seen floating in vials of the medicine.

The particles were found in batches of the drug distributed between January and June of this year.

They 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 <4502.T>.

Velcade, known chemically as bortezomib, is approved to treat multiple myeloma and relapsed mantle cell lymphoma. It is sold by Millennium in the United States and by J&J unit Janssen-Cilag in Europe and the rest of the world.

The recall was the latest to hit J&J, which has been plagued by massive recalls of numerous consumer products, such as Children's Tylenol and Motrin, keeping those medicines off pharmacy shelves for months.

Six lots of Velcade were voluntarily recalled in Europe and Japan following five reports of floating particles in samples from two of the recalled batches after the powder form of the drug was reconstituted, according to details listed on the U.K. Medicines and Healthcare Regulatory Agency drug alert website (http://link.reuters.com/tar26q)

Another seven lots are being recalled in the United States as a precaution, Millennium said.

"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 situation is similar in the United States, with Millennium expecting about 10,000 vials to be returned from about 200,000 produced in the seven lots, as most of the drug has already been administered to patients, Pai said.

In addition, 22,300 3-mg vials, only sold in Japan, are being recalled, J&J said.

No injuries were reported and no new safety issues were identified related to the J&J recall, McLaughlin said.

The root cause of the problem has been identified and both companies said all of the recalled lots were produced prior to manufacturing process improvements that were put in place in September of 2009.

(Reporting by Bill Berkrot; Editing by Tim Dobbyn)

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