Contaminated Medical Product Alert N°1/2023
AMBRONOL syrup and DOK-1 Max syrup: contaminated product alert
WHO issued this alert on two substandard syrups identified in Uzbekistan and reported to WHO on 22 December 2022. Laboratory analysis of samples found unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants. The annex is marked as an update dated 19 May 2023, and the alert page also records identification in Cambodia, reported to WHO on 3 April 2023.1,2
- Issued
- 11 January 2023
- Issued by
- World Health Organization
- Name stated on packaging
- MARION BIOTECH PVT. LTD (Uttar Pradesh, India), the stated manufacturer
- Genuine manufacturer's statement
- WHO said that to date the stated manufacturer had not provided guarantees to WHO on the safety and quality of these products.
- Countries where detected
- Uzbekistan, Cambodia
Batches named in the alert
AMBRONOL, English packaging: AAS2203 (expiry Mar-25), AMBRONOL, Russian packaging: AAS2103 (Aug-24), AAS2202 (Dec-24), AAS2201 (Dec-24), AAS2204 (Mar-25), DOK-1 MAX, Russian packaging: DXS2104 (Apr-24), P/DXS- H/2101 (Jul-24), DXS2105, DXS2106, DXS2107, DXS2108, DXS2109 (all Aug-24), DXS2201, DXS2202, DXS2203 (all Dec-24), DXS2205, DXS2206, DXS2207, DXS2208, DXS2209, DXSH2201 (all Jul-25), DXSH2202 (expiry not reported)
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. Regulators should remove the products and notify WHO.
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°1/2023: Substandard (contaminated) liquid dosage medicines (11 January 2023)
- World Health Organization, Medical Product Alert N°1/2023: annex (PDF) (19 May 2023)