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Takeda rapped over quality control failure in Japan

Published on 19/04/13 at 12:16pm
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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.

Alinamin-F5 is an essential amino acid used to treat vitamin B1 deficiency, and in the interests of patient safety Takeda ordered a recall of a single lot of the product (No. H123) in December 2012, in order to maintain patient safety.

The cause of this mix-up is suspected to be misplacement during the manufacturing process of semi-finished products. Takeda has previously said that only one box actually reached the healthcare provider level and there are no reports of any health issues related to administration of the unlabelled ampoules.

Since the recall and an investigation production and shipping of Alinamin-5 has resumed, according to the company.

"Takeda takes this sanction of the OPMA very seriously," said the company, adding that it will "enhance measures regarding Nihon Pharmaceutical … to prevent the occurrence of a similar incident in the future".

The firm also said it will develop ways to improve its oversight and management of other contract manufacturers in its production network.

Meanwhile, Takeda has filed for approval in Japan of pandemic influenza vaccines (H5N1 and a rapid-response prototype caused by other strains of the flu virus) made using cell culture technology at its Hikari facility. The company and partner Baxter have already sought approval in Japan for pandemic flu vaccines made at a plant in Europe.   

Phil Taylor

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