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January 14, 2023: The WHO has issued a Medical Product Alert on India’s Marion Biotech’s Ambronol and DOK-1 Max syrups as they failed to meet quality standards.
The Indian company has not provided guarantees to WHO on the safety and quality of these products, according to a WHO statement.
In December last year Uzbekistan alleged 18 children died in Samarkand city following the consumption of cough syrup Dok1 Max.
According to the WHO laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and or ethylene glycol as contaminants.
“Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions.
“The substandard products referenced in this Alert are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.
“It is important to detect and remove these substandard products from circulation to prevent harm to patients,” according to the WHO statement.
India has suspended the production licence of Noida-based pharmaceutical firm Marion Biotech.