Contaminated Medical Product Alert N°8/2023
ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension and ZINCELL Syrup: contaminated product alert
WHO issued this alert on five syrups and suspensions notified to WHO on 8 November 2023, first detected in the Maldives and Pakistan. The Therapeutic Goods Administration of Australia confirmed all five tested ALERGO batches were contaminated with ethylene glycol at 0.62 to 0.82% w/w, against a limit of 0.10% w/w. The Drug Regulatory Authority of Pakistan ordered the manufacturer to stop producing oral liquids and issued a recall on 16 November 2023. No adverse events had been notified to WHO at the time.1,2
- Issued
- 7 December 2023
- Issued by
- World Health Organization
- Name stated on packaging
- PHARMIX LABORATORIES (PVT.) LTD, Pakistan, the stated manufacturer
- Countries where detected
- Maldives, Pakistan, Belize, Fiji, Lao People's Democratic Republic
Batches named in the alert
ALERGO Syrup: L126, B220, G204, L210, K222, J242, EMIDONE Suspension: B227, MUCORID Syrup: A210, A211, A212, A230, B201, B224, B225, C210, C227, L111, L121, ULCOFIN Suspension: B209, C223, ZINCELL Syrup: C218, Annex 1 has 23 entries. MUCORID batches A230 and B201 each appear twice with the same dates.
Advice as stated
Do not use the affected products. Anyone who used them and had an adverse reaction should seek immediate medical advice. Report suspected adverse events to the national regulatory authority or pharmacovigilance centre. WHO recommends increased testing of PHARMIX oral liquids made between December 2021 and December 2022.
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°8/2023: Substandard (contaminated) syrup and suspension medicines (7 December 2023)
- World Health Organization, Medical Product Alert N°8/2023: annex (PDF) (7 December 2023)