The contamination, reported in batches of Velcade distributed between January and June this year in Europe, the US, Japan and Malaysia, is thought to have occurred during the manufacturing process which was performed by a contract manufacturer for Millennium, now a unit of Japan's Takeda Pharmaceutical.
According to the UK Medicines and Healthcare Regulatory Agency (MHRA), six lots of the drug were voluntarily recalled in Europe and Japan after J&J received five reports of floating particles found in samples from two of the withdrawn batches.
Millennium said a further seven lots have been called back in the US as a precaution though no complaints of adverse affects related to the J&J recall have been made.
In Europe, a total of 195,000 vials of the 3.5mg dose of Velcade have been requested back, but J&J only expects to regain 20,000 vials as most of the lots are thought to have already been consumed. Japan has been asked to return 22,300 3mg vials.
Meanwhile, in the US the drug major predicts only half of the vials will be returned out of the 20,000 vials which were produced in the seven lots.
A spokesperson for J&J said the cause of the problem has been now been identified and the recalled Velcade were produced before improvements to Takeda’s manufacturing process went ahead in September 2009.
This recall of Velcade is the latest blow to J&J which has made over 40 recalls of its medicines in the past year alone. Most recently, the firm were forced to take its Tylenol and Motrin drugs off the shelves along with some children’s medicines.
The products, produced by McNeil Consumer Healthcare, were recalled after being contaminated by the chemical 2,4,6-tribromoanisole (TBA), which comes from wood pallets used to transport and store packaging materials for the drugs.