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

JAKARTADAILY.ID – The Food and Drug Supervisory Agency (BPOM) found five medicinal products containing ethylene glycol contamination exceeding the predetermined threshold.

In a statement uploaded to the BPOM website Thursday, October 20, 2022, it was stated that BPOM had conducted research on 39 sampling batches of 26 drug syrups suspected to contain ethylene glycol (EG) and diethylene glycol (DEG).

The drug syrup which is suspected to contain EG and DEG contamination may come from 4 additional ingredients, namely propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol.

Also Read: Indonesian Ministry of Health Detected Three Chemicals in that Caused Acute Kidney Injuries in Children

BPOM uses 4 criteria for sampling and testing, including drug products suspected of being used by patients with acute kidney failure before and during the hospital stay.

Drug products are produced by manufacturers using 4 (four) raw materials as solvents for propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol in large volumes.

Medicinal products are produced by manufacturers who have a track record of minimal compliance in fulfilling quality aspects and are obtained from supply chains that are thought to come from sources that are at risk related to quality.

Also Read: MoH Orders Pharmacies to Stop Selling Syrup-Based Medicine Due to String of Acute Kidney Injury Among Children

The results of sampling and testing on 39 batches of 26 medicinal syrups up to October 19, 2022, showed the presence of EG contaminants that exceeded the safe threshold in the following 5 (five) products.