The World Health Organization (WHO) has issued a fresh global alert regarding an Indian-made cough syrup called “Cold Out,” which is being sold in Iraq.
The medication was found to be contaminated with toxins.
“The substandard batch of the product is unsafe and its use, especially in children, may result in serious injury or death,” the alert warned.
This is the fifth such warning being issued against an Indian pharmaceutical manufacturer in the past 10 months.
The syrup was manufactured by Fourrts (India) Laboratories for Dabilife Pharma and it contained contaminants higher than the acceptable level, said the WHO.
The batch of syrup found on the Iraqi market had 0.25% of diethylene glycol and 2.1% of ethylene glycol. The acceptable safety limit for both is up to 0.10%, the WHO said.
The agency added that the manufacturer and marketer have not provided guarantees to the WHO on the safety and quality of the product.
The WHO listed the “toxic effects” of the syrup as “abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”
Last year, cough syrups made by Maiden Pharmaceuticals in India were linked to the death of at least 89 children in Gambia and Uzbekistan.
Toxins were also found in a cough syrup made by Riemann Labs which were linked to deaths in children in Cameroon.
In March, Marion Biotech, which exported syrups to Uzbekistan, lost its license and some of its employees were arrested after 18 children died from the product.
