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The National Agency for Food and Drug Administration and Control (NAFDAC) issued a warning on Tuesday regarding the circulation of counterfeit Artemether/Lumefantrine tablets marketed as Aflotin 20/120 in Nigeria.
The agency announced via its Twitter page that the counterfeit product was identified and reported by Ajanta Pharma Limited, the legitimate manufacturer based in Mumbai, India.
NAFDAC indicated that Ajanta Pharma noted the counterfeited batch number PA2128L was produced in December 2018 and set to expire in November 2020.
This specific batch was originally intended for Combisunate 20/120 (Artemether 20mg/Lumefantrine 120mg Tablets) packaged in 30 x 24 tablets, but it has since been counterfeited and is now being sold as Aflotin 20/120mg in 1 x 18 tablet packs.
Furthermore, it was highlighted that the overprinted information on the counterfeit did not align with Ajanta's known overprinting techniques.
The agency confirmed that the Aflotin 20/120mg with Batch No: PA2128L found in the Nigerian market is indeed counterfeit, as determined by investigations and product evaluations.
“The authentic Aflotin 20/120 tablet consists of a combination of Artemether/Lumefantrine (20mg/120mg) and is primarily utilized for treating uncomplicated malaria caused by the Plasmodium falciparum parasite,” the agency stated.
NAFDAC underscored that counterfeit medications pose a risk to public health since they do not meet regulatory standards, compromising the safety, quality, and effectiveness of these products. “Using counterfeit medicines may lead to ineffective treatment of diseases or conditions, resulting in severe health issues, including death,” warned NAFDAC.
The agency has informed all zonal directors and state coordinators to conduct surveillance and eliminate any counterfeit products discovered in their respective areas. NAFDAC also urged distributors, retailers, healthcare providers, and caregivers to remain vigilant throughout the supply chain to prevent the distribution, sale, and use of counterfeit items. It advised that medical products should be sourced only from authorized or licensed suppliers.
