Administrative Sanction Related to Voluntary Recall of ALINAMIN®-F5 Injection in Japan

Administrative Sanction Related to Voluntary Recall of ALINAMIN®-F5 Injection in Japan

Osaka, Japan, February 13, 2013 --- Takeda Pharmaceutical Company Limited ("Takeda") today received an Order for Corrective Action regarding the manufacturing and marketing of ALINAMIN®-F5 Injection from the Osaka Prefectural Government, citing a violation of the Pharmaceutical Affairs Act associated with the voluntary recall of ALINAMIN®-F5 Injection, Lot H123. Also today, the manufacturing site of this product, the Osaka Plant (located in Izumisano City) of NIHON PHARMACEUTICAL CO., LTD, a contract manufacturer and subsidiary of Takeda, received the order for temporary suspension of its operations from the Osaka Prefectural Government for the period of 12 days from February 14 to February 25.

The background for this issue is as follows:
In December 2012 at a medical institution, one box with the outer label of ALINAMIN®-F5 Injection was discovered to contain ampoules without individual labels on them. As a result of investigation, the ampoules were found to be samples for testing purposes containing methionine (an essential amino acid) and glucose. On December 21, 2012, Takeda initiated a voluntary recall of Lot No.H123 in consideration of patient safety, which is Takeda's top priority. The recall was completed on January 31, 2013, and 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.

As the Marketing Authorization Holder of this product, Takeda has been issued an Order for Corrective Action by the Osaka Prefectural Government pointing out the lack of appropriate instructions given to NIHON PHARMACEUTICAL CO., LTD related to manufacturing control and quality control. In accordance with the Order for Corrective Action, Takeda will promptly submit a Report for Corrective Action to the Osaka Prefectural Government.

Takeda takes this administrative sanction very seriously, and deeply regrets any concern it may cause for patients and other stakeholders. We will immediately instruct NIHON PHARMACEUTICAL CO., LTD to take appropriate measures to prevent the occurrence of a similar incident in the future, and will also work to more appropriately manage and oversee other contract manufacturers of Takeda hereafter.