Takeda has received a sanction from the Japan Pharmaceutical Manufacturers Association (JPMA) for a violation of the Pharmaceutical Affairs Act related to the voluntary recall of Alinamin -F5 injection in Japan that occurred in December 2012.
The sanction involves the temporary suspension of Takeda's activities as vice president of the JPMA for the period of six months starting from 21March 2013.
In December 2012 at a medical institution, one box with the outer label of Alinamin -F5 injection was discovered containing ampoules without individual labels on them.
As a result of the investigation, the ampoules were found to be samples for testing purposes containing methionine (an essential amino acid) and glucose.
NIHON, a contract manufacturer and subsidiary of Takeda, has also received a sanction of suspension of its membership in the JPMA for Alinamin -F5 injection.
Takeda said it will work to further appropriately manage and oversee other contract manufacturers in future.
