CMO plant shut down after Takeda product recall
pharmafile | February 19, 2013 | News story | Manufacturing and Production |Â Â CMP, OPG, TakedaÂ
Japan’s regulatory authorities flexed their enforcement muscles last week when it ordered a temporary shutdown of the contract manufacturer for one of Takeda Pharmaceutical’s injectable dietary supplement products.
The Osaka Prefectural Government (OPG) ordered the closure of Nihon Pharmaceutical’s facility in Izumisano City for 12 days, after it was discovered that test samples of the Alinamin-F5 (fursultiamine HCl) product had inadvertently been introduced into the production line and entered the supply chain. Alinamin-F5 is used to treat vitamin B1 deficiency.
A medical institution discovered one box of Alinamin-5 with no labels on the ampoules, leading Takeda to order a recall of the entire lot (No. H123).
“As a result of investigation, the ampoules were found to be samples for testing purposes containing methionine (an essential amino acid) and glucose,” said Takeda, which completed the product recall at the end of January.
The cause for this incident is suspected to be misplacement during the manufacturing process of semi-finished products.
“The box containing the unlabelled 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,” said Takeda.
The company stressed that only one box actually reached the healthcare provider level and there are no reports of any health issues related to administration of the unlabelled ampoules.
The firm has been issued a corrective order by the OPG on the grounds that it had failed to provide ‘appropriate instructions’ to Nihon Pharmaceutical related to manufacturing control and quality control.
Phil Taylor
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