Takeda Pharmaceutical Co. Ltd. Penalized Over Quality Failure

Takeda Pharmaceutical has been penalised by its local trade organisation over the quality failings that led to the recall of an injectable dietary supplement product. The Osaka Pharmaceutical Manufacturers Association (OPMA) has suspended Takeda's activities as chair of the good manufacturing practice (GMP) committee, and vice-chair of the pharmaceutical laws and regulations committee for six months from 29 March. Meanwhile, the contract manufacturing organisation (CMO) which actually made the recalled product - Nihon Pharmaceutical Co - has had its membership of the OPMA suspended. In February, the Osaka Prefectural Government (OPG) ordered the closure of Nihon Pharma's facility in Izumisano City for 12 days after it was discovered that unlabelled test samples of the Alinamin-F5 (fursultiamine HCl) product, had inadvertently been introduced into the production line and entered the supply chain.

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