The National Agency for Food and Drug Administration and Control (NAFDAC)
has notified the public about five contaminated syrups allegedly going around in World Health Organisation (WHO) regions.
The notification is contained in a public alert No. 037/2023, signed by the Director-General of the agency, Prof. Mojisola
Adeyeye, a copy of which was obtained by our correspondent today.
The agency listed the WHO regions to include: America, Eastern Mediterranean, South-East Asia and Western Pacific.
It stated that the five oral liquid dosage forms (syrup and suspension) were also detected in the Maldives and Pakistan and that some of the affected products have also been detected in Belize, Fiji and Lao People’s Democratic Republic.
The agency listed the syrups as: ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension and ZINCELL Syrup, adding that “a total of 23 batches of the products are affected and the stated manufacturer is
PHARMIX LABORATORIES (PVT.) LTD (Pakistan).
“In November 2023, samples of five different batches of ALERGO syrup were screened for non-compliance by the quality control laboratory of the Maldives Food and Drug Authority (MFDA).
“This is in accordance with the Thin Layer Chromatography (TLC) test for Diethylene Glycol and Ethylene Glycol for inclusion in the International Pharmacopoeia.
“The routine screening detected potentially unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
“Laboratory testing conducted by the Therapeutic Goods Administration of Australia (TGA) confirmed that all five batches
were contaminated with ethylene glycol at levels ranging from 0.62 to 0.82 per cent w/w relative to the accepted limit of not more than 0.10% w/w.
“A follow-on inspection of PHARMIX LABORATORIES (PVT.) LTD was conducted by the Drug Regulatory Authority of Pakistan (DRAP).
“The DRAP review of the manufacturing facility and manufacturing records suggested that diethylene glycol/ethylene glycol as contaminants may be present in other products and batches manufactured by PHARMIX LABORATORIES (PVT.) LTD.
“The safety and quality of these products can, therefore, not be guaranteed,” Adeyeye quoted DRAP as saying.
The NAFDAC boss said that as a precautionary measure, DRAP had instructed PHARMIX LABORATORIES to stop production of all oral liquid dosage medicines and issued
a Recall Alert for the five different oral dosages manufactured by the company.
She disclosed that Diethylene Glycol and Ethylene Glycol are toxic to humans when consumed and can prove fatal.
According to her, 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 NAFDAC boss stated that manufacturers of liquid dosage forms, especially syrups that contain excipients, are at risk of contamination with EG/DEG such as glycol, sorbitol, and/or glycerin/glycerol.
Adeyeye added that the substandard products referenced in the alert are unsafe and that their use, especially in children, may result in serious injury or death.
She stated that although the products are not registered by NAFDAC, they may have been distributed through formal and informal markets to other countries or regions, including Nigeria.
She implored importers, distributors, retailers and consumers to exercise caution and increase vigilance within the supply chain to avoid the importation, distribution, sale and use of substandard cough syrups.
She said all medical products must be obtained from authorised/licensed suppliers, adding that products’ authenticity and physical condition should be carefully checked when buying.
The director-general advised the public, who have the listed products not to sell or use the products, but submit stock to the nearest NAFDAC office.
She urged those who may have used the products to seek immediate medical advice from qualified healthcare professionals.
She also advised healthcare professionals and consumers to report any suspicion of adverse drug reactions, or substandard and falsified medicines to the nearest NAFDAC office on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.
She encouraged healthcare professionals and patients to report adverse or side effects related to the use of the medicinal product to the nearest NAFDAC office, or
through the use of E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
