The recall is a “precaution” after five reports of visual particulates were received following product reconstitution in samples from two batches, according to a statement yesterday on the website of the U.K.’s Medicines and Healthcare Products Regulatory Agency. The six affected batches of the medicine, sold in powder form in 3.5-milligram strength, were first distributed from Jan. 5 to June 16, the statement said.
J&J has recalled more than 40 of its medicines in the last year, some of them children’s medicines. U.S. lawmakers and regulators investigated J&J in connection with a recall of over- the-counter-painkillers last year, and another this year of children’s drugs from the McNeil Consumer Healthcare unit.
A manufacturing problem linked with the particulates is being fixed, Seizo Masuda, a spokesman for Takeda in Tokyo, said today. Velcade is sold by Takeda’s Millennium unit in the U.S. and by Johnson & Johnson in other countries.
Johnson & Johnson was unchanged at $63.83 at 4:01 p.m. in New York Stock Exchange composite trading. Takeda fell 0.4 percent to 3,955 yen at the 3 p.m. close in Tokyo trading. The benchmark Topix index gained 0.1 percent.
Sales of Velcade rose 12 percent to 25.6 billion yen ($307 million) in the six months ended Sept. 30 and made up 3.6 percent of total revenue, Takeda, Asia’s largest drugmaker, said on Oct. 29. The company bought Millennium, based in Cambridge, Massachusetts, in 2008 for $8.9 billion and added the product to its portfolio.
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