Contaminated Medical Product Alert N°7/2022
Termorex syrup, Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Demam Paracetamol Drops, Unibebi Demam Paracetamol Syrup, Paracetamol Drops, Paracetamol Syrup (mint) and Vipcol Syrup: contaminated product alert
WHO issued this alert on eight substandard paediatric liquid medicines identified in Indonesia and reported to WHO by Badan POM on 20 and 30 October 2022. Analysis by the Indonesian authorities found unacceptable levels of ethylene glycol and/or diethylene glycol as contaminants. WHO said the products may have reached other countries or regions through informal markets.1,2
- Issued
- 2 November 2022
- Issued by
- World Health Organization
- Name stated on packaging
- The annex gives these stated manufacturers: PT Konimex (Termorex), PT Yarindo Farmatama (Flurin DMP), PT Universal Pharmaceutical Industries (the three Unibebi products) and PT Afi Farma (Paracetamol Drops, Paracetamol Syrup (mint) and Vipcol Syrup).
- Countries where detected
- Indonesia
Batches named in the alert
AUG22A06 (Termorex, manufactured AUG 2022, expiry AUG 2025), All batches of the other seven products
Advice as stated
Do not use the listed products. Anyone who used them or had an adverse reaction should seek medical advice and report it to the national regulatory authority or pharmacovigilance centre. Manufacturers should test liquid dosage forms and excipients such as propylene glycol, polyethylene glycol, sorbitol and glycerin for these contaminants.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°7/2022: Substandard (contaminated) paediatric liquid dosage medicines (2 November 2022)
- World Health Organization, Medical Product Alert N°7/2022: annex (PDF) (2 November 2022)