One batch of COLD OUT — paracetamol and chlorpheniramine combination syrups used to treat symptoms of the common cold and allergy — manufactured by Fourrts India for Dabilife Pharma Private Limited has been reported to the World Health Organization (by a third party) as substandard or contaminated.
In a medical product alert issued on Monday, the WHO said: “COLD OUT syrup (Paracetamol and Chlorpheniramine Maleate) identified in the Republic of Iraq and reported to the WHO on 10 July 2023 by a third-party sample was found contaminated.”
“A sample of the COLD OUT Syrup was obtained from one location in Iraq and submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%,” it said, adding that to date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.
