J&J and Takeda issue recall for cancer drug Velcade
pharmafile | November 22, 2010 | News story | Manufacturing and Production | J&J, JJ, Johnson & Johnson, Takeda Pharmaceuticals, Velcade, bortezomib, pharma manufacturing, product recalls
Johnson & Johnson has been affected by another product recall, on this occasion concerning the cancer drug Velcade (bortezomib) sold by its Janssen-Cilag unit alongside Takeda Pharmaceuticals.
Given the problems J&J has had of late with its own manufacturing network, it will be something of a relief for the company that this time it was not responsible for manufacturing the defective product.
J&J and Takeda initiated the recall of Velcade 3.5mg vials sold in Europe, the US, Japan and Malaysia because of white particulate matter – said to be a polyester-like material – seen floating in vials from two batches of the drug, says a Bloomberg report.
The batches were made by a contract manufacturer on behalf of Millennium Pharmaceuticals, the Takeda unit which originally developed Velcade and sells it in the US for treating multiple myeloma and relapsed mantle cell lymphoma. Janssen-Cilag markets it in Europe and the rest of the world.
The recall affects six lots of Velcade distributed in Europe and Japan, with another seven lots being pulled in the US. Many of the estimated 400,000 vials affected by the recall will already have been used, said the companies, but there have been no reports of any adverse reactions related to the issue.
“Janssen-Cilag Limited is recalling all remaining stock of all the above batches as a precaution,” said the UK Medicines and Healthcare products Regulatory Agency (MHRA) in a statement.
“This is because the company has received five reports of visual particulates after product reconstitution in samples from two batches.”
The companies said all of the recalled lots were made before manufacturing process improvements were put in place in September 2009.
Although not at fault in this case, the latest recall will not help J&J rebuild its manufacturing reputation in the wake of massive recalls of its over-the-counter medicines and good manufacturing practice (GMP) violations at multiple manufacturing facilities which emerged over the course of 2010.
The company is already fighting a number of shareholder actions alleging that it breached its fiduciary duty in failing to maintain GMP standards at production facilities which resulted in product recalls. Another lawsuit which sought to compel the company to disclose records relating to the recalls and the activities of various manufacturing plants was dismissed last month.
Phil Taylor
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