The WHO on Monday issued a 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 manufacturer in the past 10 months.
Alert on toxins and its effects
The syrup was manufactured by Fourrts (India) Laboratories for Dabilife Pharma and it contained contaminants higher than the acceptable level, said the WHO.
However, Bala Surendran, the vice president of the company, told Bloomberg news last month that the production of the medicine had been subcontracted to another company and that his company had not found any toxins in a sample they had reviewed.
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.”
The Ministry of Health in India announced that after the medicine failed separate tests conducted in Iraq, products were now being confiscated from the market, reported Bloomberg.
India faces series of medical alerts
Last year cough syrups made by Maiden Pharmaceuticals in India were linked to the death of at least 89 children in Gambia and Uzbekistan.
Indian authorities also found toxins 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.
This year India mandated testing of cough syrups before exports to prevent such instances, reported the Indian Express.
Reuters contributed to this article.