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From Fred Ezeh, Abuja
National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted Nigerians on two substandard/contaminated products, namely, AMBRONOL syrup and DOK-1 Max syrup, identified in Uzbekistan in Europe and reported to the World Health Organisation (WHO).
NAFDAC said the substandard medical products failed to meet quality standards or specifications and are therefore out of specification. The agency, in a statement, posted on its twitter account, noted that 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 amount of diethylene glycol and/or ethylene glycol as contaminants.
NAFDAC said the manufacturer of both products is Marion Biotech PVT. Ltd., (Uttar Pradesh, India) has not provided guarantees to WHO on the safety and quality of the products.
NAFDAC explained that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. It added that its 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.
“These substandard products are, therefore, unsafe and their use, especially in children, may result in serious injury or death,” the agency said.
NAFDAC, therefore, implored manufacturers of liquid dosage forms, especially syrups that contain excipients, including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin /glycerol, to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.
