BPOM Temukan Obat Yang Mengandung EG Dan DEG

Intinews | Badan Pengawas Obat dan Makanan (POM) merilis sirup obat yang diduga mengandung cemaran Etilen Glikol (EG) dan Dietilen Glikol (DEG). Temuan itu berdasarkan pengujian terhadap 39 bets dari 26 sirup obat sampai dengan 19 Oktober 2022 lalu yang menunjukkan adanya kandungan cemaran EH melebihi ambang batas aman pada lima produk sirup obat.

Melalui keterangan resminya Kamis (20/10/2022) dikatakan sirup obat yang diduga mengandung EG dan DEG memungkinkan berasal dari empat bahan tambahan. Yaitu propilen glikol, polietilen glikol, sorbitol, dan gliserin/gliserol.

“Keempat bahan itu yang bukan merupakan bahan yang berbahaya atau dilarang digunakan dalam pembuatan sirup obat. Sesuai Farmakope dan standar baku nasional yang diakui, ambang batas aman cemaran EG dan DEG sebesar 0,5 mg/kg berat badan per hari,” seperti keterangannya.

Berikut sirup obat yang mengandung zat tersebut, pertama, Termorex Sirup (obat demam) produksi PT Konimex dengan nomor izin edar DBL7813003537A1, kemasan dus, botol plastik @60 ml.

Kedua, Flurin DMP Sirup (obat batuk dan flu) produksi PT Yarindo Farmatama dengan nomor izin edar DTL0332708637A1, kemasan dus, botol plastik @60 ml.

Ketiga, Unibebi Cough Sirup (obat batuk dan flu) produksi Universal Pharmaceutical Industries dengan nomor izin edar DTL7226303037A1, kemasan dus, botol plastik @60 ml.

Keempat, Ubebi Demam Sirup (obat demam) produksi Universal Pharmaceutical Industries dengan nomor izin edar DBL8726301237A1, kemasan dus, botol plastik @60 ml.

Kelima, Ubebi Demam Drops (obat demam) produksi Universal Pharmaceutical Industries dengan nomor izin edar DBL1926303336A1, kemasan dus, botol plastik @15 ml.

“Badan POM telah melakukan tindak lanjut dengan memerintahkan kepada industri farmasi pemilik izin edar untuk melalukan penarikan sirup obat dari peredaran di seluruh Indonesia dan pemusnahan untuk seluruh bets produk,” seperti kutipannya lagi.

Badan POM memerintahkan semua industri farmasi yang memiliki sirup obat yang berpotensi mengandung cemaran EG dan DEG untuk melaporkan hasil pengujian mandiri sebagai bentuk tanggung jawab pelaku industri usaha.

Industri farmasai juga dapat melakukan upaya lain seperti mengganti formula obat dan/atau bahan baku jika diperlukan. (**)

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