From Fred Ezeh, Abuja
The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted Nigerians of 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 an 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.
It said that although the products are not in its database, it advised importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) syrups, insisting that all medical products must be obtained from authorised/licensed suppliers, and the product’s authenticity and physical condition should be carefully checked.
NAFDAC advised members of the public in possession of the above-listed products to discontinue sale or use and submit stock to the nearest NAFDAC office.
“If you have these substandard products, please do not use them. If you or someone you know have used these products or suffered any adverse reaction after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
“Healthcare professionals and consumers are also encouraged to report adverse events or side effects related to the use of these products to the nearest NAFDAC office,” the Agency added.