Takeda, CMO hit with sanctions by Japanese regulator
While the FDA may sit atop the heap of drug regulators in the world, drugmakers have to thread their way through the regulatory landscape in every country in which they sell their products. Takeda Pharmaceutical and one of its contract manufacturers have now run afoul of authorities in Japan, leading to the temporary closure of a manufacturing plant.
The Japanese drugmaker said the Osaka Prefectural Government has ordered Nihon Pharmaceutical to close down for 12 days after Takeda had to recall a lot of its Alinamin-F5 dietary supplement sold in Japan for vitamin B1 deficiency.
Takeda said in December that a "medical institution" discovered that a box labeled as Alinamin-F5 contained ampules that were missing any identifying labels. Tests determined that they were filled with methionine and glucose and were samples for testing. Takeda voluntarily recalled the lot and by Jan. 31, it had all of the product in hand. It said only the one box had made it to a medical provider and that there were no reports of patients being injected from the mixed vials.
The company figured out that the box containing the samples was being used to determine the correct placement of the label on the outer box but "was mistakenly put into the actual manufacturing line of the real product."
In November 2010, Takeda and Johnson & Johnson ($JNJ) recalled certain lots of their blood-cancer drug Velcade from North America, Europe and Asia after 5 reports of post-reconstitution visible particles. That product also was manufactured for the companies by a contract manufacturer.
J&J, Takeda recall contaminated Velcade