The National Agency for Food and Drugs Administration and Control (NAFDAC) has raised the alarm over five substandard (contaminated) syrup and suspension medicines identified in the Maldives and Pakistan.
In a statement published on its website on Thursday, December 28, NAFDAC said that there is a World Health Organisation (WHO) Medical Product Alert on the five products.
According to NAFDAC, the five products are ALERGO Syrup, EMIDONE Suspension, MUCORID Syrup, ULCOFIN Suspension and ZINCELL Syrup, all manufactured by PHARMIX LABORATORIES (PVT.) LTD (Pakistan).
The agency said a total of 23 batches of these products are affected.
The agency said that besides Maldives and Pakistan, some of the affected products have also been detected in Belize, Fiji and Lao People’s Democratic Republic.
NAFDAC disclosed that these substandard products are unsafe and their use, especially in children, may result in serious injury or death.
“Although these products are not registered by NAFDAC, they may have been distributed, through formal and informal markets, to other countries or regions including Nigeria.
“NAFDAC implores importers, distributors, retailers and consumers to exercise caution and increase vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard cough 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 not to sale or use the products, instead they are to submit stock to the nearest NAFDAC office,” the agency said.
Giving a background about the products, NAFDAC said, “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) 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% 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). According to DRAP, a 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.
“As a precautionary measure PHARMIX LABORATORIES has been instructed by DRAP to stop production of all oral liquid dosage medicines and issued a Recall Alert for the five different oral dosage forms manufactured by PHARMIX LABORATORIES.
“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,” NAFDAC said.
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