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6 Dec 2022


Indonesia: WHO alert says 8 paediatric medicines in Indonesia contain dangerous levels of ethylene glycol and/or diethylene glycol – liquids typically used in antifreeze

"Medical Product Alert N°7/2022: Substandard (contaminated) paediatric liquid dosage medicines" 2. November 2022

This WHO Medical Product Alert refers to eight substandard products, identified in the WHO Region of South-East Asia. These products were identified in Indonesia and publicly reported by the national regulatory authority (Badan POM) on 20 and 30 October 2022[1]. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore "out of specification"[2].

The eight products are Termorex syrup (batch AUG22A06 only), Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, Paracetamol Drops (manufactured by PT Afi Farma), Paracetamol Syrup (mint) (manufactured by PT Afi Farma) and Vipcol Syrup. Please see the annex for further details.

These products contain unacceptable amounts of ethylene glycol and/or diethylene glycol as contaminants: this has been confirmed by laboratory analysis of samples by the authorities in Indonesia. To date, these products have been identified in Indonesia. They may however have marketing authorizations in other countries. These products may have been distributed, through informal markets, to other countries or regions.