Jakarta, IO – The Food and Drug Monitoring Agency (BPOM) has decided to revoke the distribution licenses of three pharmaceutical companies which use excessive Propylene Glycol as solvent and cough syrups that contain Ethylene Glycol (EG) in excess of safe limit which may cause atypical progressive acute kidney injury (AKI).
The three companies are PT Yarindo Farmatama, PT Universal Pharmaceutical Industries, and PT Afi Farma, reported CNN Indonesia (8/11).
“The results of the investigation and enhanced BPOM supervision through inspection, expansion of sampling, testing of samples of medicinal syrup products and additional materials used, as well as further inspection of production facilities, it is concluded that the three pharmaceutical industries have committed violations in the production process,” said BPOM.
BPOM ordered the three pharmaceutical firms to stop production and revoked their distribution licences. Furthermore, they have to withdraw their products from the market, including distributors, pharmacies, drug stores, and other pharmaceutical service facilities and to destroy all remaining stockpiles in the presence of BPOM officials and submit report on the destruction.