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WHO flags contaminated India-made cough syrup in Iraq

The sample of the cough syrup had more than permissible limits of diethylene glycol and ethylene glycol as revealed in a laboratory analysis.

The World Health Organization (WHO) flagged a batch of contaminated Indian-manufactured cough syrup identified in the Republic of Iraq. The syrup was reported to the WHO on July 10, 2023, by a third party, and WHO stated that the product may have been marketed, and distributed in other countries as well.

A​ sample of the product, COLD OUT syrup (paracetamol and chlorpheniramine maleate) was obtained from one location in Iraq and submitted for laboratory analysis. The results revealed that it contained unacceptable amounts of diethylene glycol (0.25 per cent) and ethylene glycol (2.1 per cent) as contaminants. The acceptable safety limit for diethylene glycol and ethylene glycol is 0.10 per cent or under. The contaminated batch of the product was manufactured for Fourrts (India) Laboratories Pvt. Ltd. for Dabilife Pharma Pvt. Ltd. The stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.

D​iethylene glycol and ethylene glycol are said to have toxic effects on humans. Symptoms can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury, leading to a fatality, as per WHO.

T​he agency recommends that people in possession of the affected product stop usage immediately. In case of consumption of the said product, medical advice from a healthcare professional is recommended. Those with information about the manufacture and supply of the said products are advised to contact WHO via rapidalert@who.int.​

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