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BPOM assures total recall of drugs allegedly tied to deaths
The Food and Drug Monitoring Agency (BPOM) has assured the total recall of anesthetic Buvanest Spinal and antihemorrhagic Asam Tranexamat Generik following the deaths of two hospital patients on Feb
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T
he Food and Drug Monitoring Agency (BPOM) has assured the total recall of anesthetic Buvanest Spinal and antihemorrhagic Asam Tranexamat Generik following the deaths of two hospital patients on Feb. 12.
'We are closely monitoring the recall. The drugs are no longer in circulation,' Roy said at his office.
The BPOM had ordered the producer of the drugs, Kalbe Farma, the largest pharmaceutical firm in the country, to recall and stop producing the drugs after two patients at Siloam Hospital in Karawaci, Tangerang died after being administered with Buvanest Spinal.
BPOM investigators suspect that an accidental swap of the two drugs caused the deaths. The incident occurred during urological surgery on one patient and C-section on another.
Roy said the BPOM was still conducting a cross-sectoral investigation.
'The investigation could last one to two months, we will announce the results,' he said as quoted by Antara news agency.
Health Minister Nila F. Moeloek, meanwhile, said that the ministry would monitor the investigation. She said that to understand the incident, 'we should look at several aspects, specifically the hospital, industry and distribution.'
BPOM legal and public relations head Budi Djanu said that the agency did not find any irregularities in other recalled drugs.
