The Osaka Prefectural Government has issued an order for corrective action concerning the manufacturing and marketing of ALINAMIN-F5 injection to Takeda Pharmaceutical Company.
A violation of the Pharmaceutical Affairs Act coupled with the voluntary recall of ALINAMIN-F5 Injection, Lot H123, was mentioned in the order.
Nihon Pharmaceutical, the contract manufacturer and subsidiary of Takeda, has received the order for temporary suspension of Osaka plant operations for 12 days from 14 February 2013 to 25 February 2013.
In line with the order for corrective action, Takeda is expected to submit a report for corrective action to the Osaka Prefectural Government.
In December 2012, a box was indentified with the outer label of ALINAMIN-F5 injection and containing ampoules without individual labels, which were latter found to be samples for testing purposes containing methionine and glucose.
On 21 December 2012, Takeda voluntarily recalled certain lots and verified the shipment of single box to a medical institution.