Takeda Voluntarily Recalls a Specific Lot of its Fursultiamine HCl Preparation, ALINAMIN®-F5 Injection in Japan

Takeda Voluntarily Recalls a Specific Lot of its Fursultiamine HCl Preparation, ALINAMIN®-F5 Injection in Japan

Osaka, Japan, December 21, 2012 – Takeda Pharmaceutical Company Limited ("Takeda") announced today its decision to voluntarily recall Lot No.H123 of ALINAMIN®-F5 Injection, 50 ampoules per box (generic name: Fursultiamine HCl), that is marketed in Japan for the treatment of vitamin B1 deficiency. The recall starts today December 21, 2012.

The background for this recall is as follows:

One box with the outer label of ALINAMIN®-F5 Injection containing ampoules without labels on them was found at a medical institution, and such ampoules had been shipped from Takeda's contract manufacturer, NIHON PHARMACEUTICAL CO., LTD, which is a subsidiary of Takeda. As a result of investigation, the ampoules were found to be samples for testing purpose containing methionine (an essential amino acid) and glucose. The cause for this incident is suspected to be misplacement during the manufacturing process of semi-finished products. The box containing the unlabeled ampoules was prepared only for the purpose of testing the label placement on the outer box, but the box was mistakenly put into the actual manufacturing line of the real product.

There have been no reports of health injury due to the administration of the said ampoules up to the moment, however, we have decided to voluntarily recall the Lot No.H123 in consideration of patient safety which is the top priority for Takeda.

We deeply regret this issue and any potential concerns among all our stakeholders, and we are committed to immediately take appropriate actions to prevent the same issue in the future. At the same time, we are swiftly starting measures to provide accurate information on this recall to healthcare providers in order to avoid confusion among the patient population and healthcare providers who treat them.

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