Indonesia's FDA Recalls Five Syrup-Based Medicine that Allegedly Caused Acute Kidney Injury in Children

- 21 October 2022 18:53 WIB
Laboratory of the Food and Drug Supervisory Agency (BPOM). (Photo/ Screenshot twitter @BPOM_RI)
Laboratory of the Food and Drug Supervisory Agency (BPOM). (Photo/ Screenshot twitter @BPOM_RI)

5.Unibebi Fever Drops (fever medicine), produced by Universal Pharmaceutical Industries with distribution license number DBL1926303336A1, Box packaging, Bottle @ 15 ml.

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However, BPOM stated that the results of the EG contamination test could not support the conclusion that the use of the drug syrup has a relationship with the incidence of acute kidney failure.

This is because, in addition to the use of drugs, there are still several risk factors that cause acute kidney failures such as viral infections, Leptospira bacteria, and multisystem inflammatory syndrome in children (MIS-C) or post-COVID-19 multisystem inflammatory syndrome.

"With respect to the test results of 5 (five) drug syrups with EG content that exceeds the safe threshold as stated in point 5, BPOM has followed up by ordering the pharmaceutical industry holding the distribution permit to withdraw the drug syrup from circulation throughout Indonesia and destroy it for distribution. all product batches' explained BPOM.

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Previously Indonesian Ministry of Health confirmed that 99 children have died due to acute kidney injury.

"There have been 99 children who have died, out of the 99, we check that there are harmful chemical substances in them," said the Indonesian Minister of Health, Budi Gunadi Sadikin in Serang, Banten, Thursday, October 20, 2022.

 

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