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J&J, Takeda recall Velcade drug batches on particle concerns

This article was originally published in Scrip

Executive Summary

Janssen-Cilag, a unit of Johnson & Johnson, and Millennium Pharmaceuticals, a unit of Takeda, are recalling thousands of vials of the anticancer Velcade (bortezomib) sold in Europe, the US, Japan and Malaysia after receiving reports of white particulate matter – said to be polyester-like material -floating in vials of the medicine. The recall was first announced on 18 November by the UK Medicines and Healthcare Products Regulatory Agency "as a precaution" after five reports of visual particulates were received following product reconstitution in samples from two different batches, distributed between January and June of this year. Since then, the precautionary recall has been expanded to the US and Japan as well.



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