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Takeda suspended as vice president of Japanese industry body

Mis-labelling also prompts JPMA to takes action against CMO Nihon Pharmaceutical

Takeda suspended as vice president of JPMATakeda faces a six month suspension from its duties as vice president of the Japan Pharmaceutical Manufacturers Association (JPMA) as a result of a labelling error for a vitamin supplement.

According to the JPMA, which represents the pharma industry in Japan, Takeda violated the Pharmaceutical Affairs Act when boxes labelled Alinamin F5 were discovered to contain unidentified individual ampoules that did not turn out to be the correct product.

The JPMA also took action against Nihon Pharmaceutical, a contract manufacturing organisation (CMO) and Takeda subsidiary, by suspending its membership.

Takeda said it takes the sanction “very seriously" and "will enhance measures regarding Nihon Pharmaceutical to prevent the occurrence of a similar incident in the future”.

The mishap was first reported in December 2012 when a box with the outer label Alinamin-F5 injection was found to contain ampoules without a label.

When these ampoules were tested, they were demonstrated to be samples of Alinamin-F5 to be used for testing purposes. These samples contained the essential amino acid methionine and glucose.

As a result of this discovery, Takeda initiated a voluntary recall of a batch of Alinamin-F5, which was completed by the end of January 2013.

The company said: “Takeda has been able to verify that only one box was shipped to a medical institution, and that there have been no reports of health injury due to the administration of the aforementioned ampoules.”

Nevertheless, Takeda still received an order for corrective action from the regional Osaka government, leading to a temporary suspension of Nihon's plant operations in February.

Takeda also submitted a report, detailing corrective actions that it plans to take, to the government. The company will not be allowed to re-start production and shipment of Alinamin-F5 injection from the Osaka plant until it gains approval from the government.

22nd March 2013

From: Regulatory



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