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The World Health Organization (WHO) has issued a contamination alert on a sample of cold syrup obtained in Iraq and manufactured by Chennai-based Fourrts (India) Pvt Ltd.
The development comes a week after Bloomberg News reported that a bottle of Cold Out syrup purchased at a pharmacy in Baghdad contained 2.1 per cent ethylene glycol, 21 times higher than the prescribed limit.
The global news agency said the compound is lethal to humans in small amounts, and played a role in mass child deaths caused by Indian-made cough syrups in Gambia and Uzbekistan last year. Bloomberg had then said it shared the test results with WHO and Iraqi and Indian health officials.
In its latest alert, the UN agency confirmed that a sample of the syrup was found with unacceptable amounts of diethylene glycol (0.25 per cent) and ethylene glycol (2.1 per cent) as contaminants. “The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10 per cent,” it added.
The global health agency said the substandard batch of the product is unsafe and its use, especially in children, may result in serious injury or death.
WHO advised the regulatory authorities and the public to not use the product. “While this medical product alert relates to only one batch of the product, out of an abundance of caution, WHO recommends increased vigilance and testing in respect of the product in general,” it said.
no guarantees
WHO also said manufacturer (Fourrts (India)) and marketer (Dabilife Pharma Pvt Ltd) have not provided guarantees on the safety and quality of the product.
However, a Fourrts (India) official told businessline that Indian healthcare authorities have taken fresh samples of the product, and the company will decide the next course of action based on instruction received from the government. “If the product fails the test, the government may ask us to stop exporting,” he added.
WHO also called for increased surveillance within the supply chains of countries likely to be affected by this product. However, the company official clarified that the product in question was exported only to Iraq, and there is no impact on exports of its products to other countries.
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