THE National Agency for Food and Drugs Administration and Control (NAFDAC) has notified the public of two “substandard (contaminated)” cough syrups named AMBRONOL and DOK-1 Max containing “toxic” ingredients.
In a statement published Sunday on its website, the agency noted that the products were identified in Uzbekistan, a Central Asian nation and reported to the World Health Organization (WHO).
It defined substandard medical products as ones that fail to meet quality standards or specifications and are therefore “out of specification”.
According to NAFDAC, 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.
“The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.
“Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
“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,” the agency stated.
The statement reads in full:
Public Alert No. 02/2023 – Alert on Substandard (contaminated) AMBRONOL syrup and DOK-1 Max syrup
January 15, 2023,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of two substandard (contaminated) products, AMBRONOL syrup and DOK-1 Max syrup identified in Uzbekistan in Europe and reported to WHO.
Substandard medical products are products that fail to meet quality standards or specifications and are therefore “out of specification”.
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.
The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. 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.
Product Details
The details of the substandard (contaminated) syrups are as follows;
Product Manufacture Product Name
MARION BIOTECH PVT. LTD, (Uttar Pradesh, India) AMBRONOL syrup – DOK-1 Max syrup
NAFDAC implores 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.
Although the products are not in NAFDAC database, importers, distributors, retailers and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) syrups. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the above listed products are advised 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/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management