Takeda has received a sanction from the Osaka Pharmaceutical Manufacturers Association (OPMA) in Japan, for the violation of the pharmaceutical affairs act related to the voluntary recall of Alinamin-F5 Injection in the country in December 2012.
The sanction involves the temporary suspension of Takeda's activities as chairman of GMP Committee and vice chairman of Pharmaceutical Laws and Regulations Committee of OPMA for the period of six months beginning 29 March 2013.
Takeda's subsidiary and contract manufacturer for Alinamin-F5 Injection, Nihon Pharmaceutical has also received a sanction of suspension of its membership in the OPMA.
The company said it takes this sanction of the OPMA very seriously, and will enhance measures regarding Nihon Pharmaceutical to avoid the occurrence of a similar incident in the future, and will also work to further appropriately manage and oversee other contract manufacturers hereafter.
The recall was initiated as one box with the outer label of Alinamin -F5 injection was discovered containing ampoules without individual labels on them at a medical institution in December 2012.
As a result of the investigation, the ampoules were found to be samples for testing purposes containing methionine (an essential amino acid) and glucose.
