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5 Syrups contaminated with ethylene glycol, BPOM orders withdrawal


Jakarta

The Indonesian Food and Drug Supervisory Agency (BPOM) has announced the results of the examination of a number of syrup drug samples. Consequently, there were 5 products indicated by ethylene glycol (EG) contamination above the normal threshold.

However, it has been pointed out that these findings do not necessarily mean that the use of these drugs is a trigger for acute kidney failure. Other risk factors are still being studied.

“The results of sampling and testing of 39 batches of 26 medicinal syrups up to October 19, 2022, showed the presence of EG contaminants that exceeded the safe threshold in 5 (five) products,” BPOM wrote on Thursday (20 / 10/2022). .

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List of drugs containing EG above safe levels according to BPOM RI:

Termorex syrup (fever medicine)

Manufactured by PT Konimex with distribution permit number DBL7813003537A1, boxed pack, plastic bottle @ 60ml.

Flurine DMP syrup (cough and flu medicine)

Production of PT Yarindo Farmatama with distribution permit number DTL0332708637A1, packed in box, 60ml plastic bottle.

Unibebi cough syrup (cough and flu medicine)

Universal Pharmaceutical Industries Manufacturing under Distribution License Number DTL7226303037A1, Boxed Pack, 60ml Plastic Bottle.

Unibebi fever syrup (fever medicine)

Manufactured by Universal Pharmaceutical Industries under Distribution License Number DBL8726301237A1, Boxed Pack, 60ml Bottle.

Unibebi Fever Drops (fever medicine)

Manufactured by Universal Pharmaceutical Industries under Distribution License Number DBL1926303336A1, Boxed Pack, 15ml Bottle.

BPOM explained that EG and DEG contamination could come from four additional ingredients, namely propylene glycol, polyethylene glycol, sorbitol, and glycerin / glycerol. The four additions are actually not dangerous ingredients or are forbidden to use them in the production of medicinal syrups.

The investigation process related to the relationship between acute renal failure and ethylene glycol compounds contained in the drug is still ongoing.

Earlier, epidemiologist Dicky Budiman of Griffith University in Australia said that under conditions like this, the government, particularly BPOM, needs to open data on drugs that may contain contamination from hazardous materials.

“We have to minimize uncertainty, so information, correct risk communication is very important. Among other things, it is communicating, even if it is still suspected, which one is about to be contaminated or there is exposure to ethylene glycol. diethylene glycol, ”Dicky said when contacted by detikcom on Thursday (10/20/2022).

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