Jakarta Globe, Investor Daily, Mar 06, 2015
Jakarta. The Food and Drug Monitoring Agency, known as BPOM, has terminated the distribution permit for the drug Buvanest Spinal by state-controlled pharmaceutical firm Kalbe Farma due to non-compliance with good manufacturing practices.
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| Workers of Kalbe Farma factory sort out medicine tablets in Cikarang, Indonesia West Java province August 5, 2013. (Reuters Photo) |
Jakarta. The Food and Drug Monitoring Agency, known as BPOM, has terminated the distribution permit for the drug Buvanest Spinal by state-controlled pharmaceutical firm Kalbe Farma due to non-compliance with good manufacturing practices.
“[Kalbe
Farma’s] investigation report did not adequately depict the problem roots, that
there can be a potential mix-up,” said Togi Junice Hutadjulu, director of
therapeutic products monitoring at the agency, on Thursday.
Preliminary
findings from the ongoing investigation suggest Kalbe Farma incorrectly
labelled tranexamic acid as Buvanest Spinal, which resulted in the deaths of
two women undergoing Caesarian section and cystoscopy procedures at Siloam
Hospital in Tangerang last month.
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