The National Agency for Food and Drug Administration and Control (NAFDAC) has notified the public about five contaminated syrups allegedly going round in World Health Organisation (WHO) regions.
The notification is contained in a public alert number 037/2023, signed by the agency’s Director General, Prof. Mojisola Adeyeye, a copy of which was obtained by the News Agency of Nigeria (NAN) yesterday in Abuja.
The agency listed the WHO regions to include: America, Eastern Mediterranean, Southeast Asia, and Western Pacific.
It said the five oral liquid dosage forms (syrup and suspension) were also detected in the Maldives and Pakistan, adding that some of the affected products have also been detected in Belize, Fiji, and Lao People’s Democratic Republic.
NAFDAC listed the syrups as: ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension, and ZINCELL Syrup.
The agency stated that “a total of 23 batches of the products are affected and named the manufacturer as PHARMIX LABORATORIES (PVT.) LTD (Pakistan)”.
It added: “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.
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“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 per cent 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 explained that as 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 dosage manufactured by the company.
She added that Diethylene Glycol and Ethylene Glycol are toxic to humans when consumed and can prove fatal.