Contaminated Medical Product Alert N°6/2023
COLD OUT syrup (paracetamol and chlorpheniramine maleate): contaminated product alert
WHO issued this alert on one batch of COLD OUT syrup identified in Iraq and reported to WHO on 10 July 2023 by a third party. Analysis of a sample found diethylene glycol at 0.25% and ethylene glycol at 2.1%, against a limit of 0.10% for each. WHO said the product may hold marketing authorisations elsewhere and may have spread through informal markets.1,2
- Issued
- 7 August 2023
- Issued by
- World Health Organization
- Name stated on packaging
- FOURRTS (INDIA) LABORATORIES PVT. LTD, the stated manufacturer, with the product stated to be manufactured for DABILIFE PHARMA PVT. LTD., India
- Genuine manufacturer's statement
- WHO said the stated manufacturer and marketer had not provided guarantees to WHO on the safety and quality of the product.
- Countries where detected
- Iraq
Batches named in the alert
SF001A02 (expiry DEC.2024)
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.
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°6/2023: Substandard (contaminated) syrup medicines (7 August 2023)
- World Health Organization, Medical Product Alert N°6/2023: annex (PDF) (7 August 2023)