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news.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.
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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.