J&J, Takeda recall cancer drug Velcade in Europe, US, Japan, Malaysia

J&J and Takeda, which co-market Velcade, said the impurities were made of a white polyester like material that stemmed from a filtration system used in the manufacturing process.

The UK Medicines and Healthcare products Regulatory Agency issued a notice saying Johnson & Johnson’s Janssen-Cilag unit was recalling all remaining stock of six batches of the drug as a precaution, distributed between January and June this year.

The recall was the latest to hit J&J, which has been troubled by recalls of several consumer products, such as children’s Tylenol and Motrin.

Velcade is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). Velcade is also approved for the treatment of patients with mantle cell lymphoma (a cancer of lymph nodes) who have already received other treatments.

Velcade is co-developed by Millennium and Ortho Biotech Oncology Research & Development, a unit of J&J Pharmaceutical Research & Development.

Millennium is responsible for commercialisation in the US, Janssen-Cilag is responsible for commercialisation in Europe and the rest of the world.

Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical entered into a co-promote agreement in May 2010 for Velcade in Japan.

Millennium spokeswoman Manisha Pai said that in the US they have received no confirmed product complaints or adverse events related to this issue.

J&J spokeswoman Kellie McLaughlin said that the recall is a precautionary measure and they did not have any adverse events (in patients) related to the impacted lots.