The National Agency for Food and Drug Administration and Control (NAFDAC) on Tuesday alerted the public of the presence of counterfeit Artemether/Lumefantrine tablets circulating under the brand name Aflotin 20/120 in Nigeria.
The agency said on its X handle that the counterfeit product was discovered and reported to the agency by the genuine manufacturer, Ajanta Pharma Limited from Mumbai, India,
According to NAFDAC, Ajanta Pharma observed that it manufactured the counterfeited product with batch number PA2128L in December 2018, with an expiry date of November 2020.
It said the batch was created for Combisunate 20/120 (Artemether 20mg/Lumefantrine 120mg Tablets), with a pack size of 30 x 24 tablets, but had now been counterfeited and was being sold as Aflotin 20/120mg with a pack size of 1 x 18 tablets.
It added that the overprinted matter did not match Ajanta’s overprinting style.
The agency said the company had confirmed that the Aflotin 20/120mg with Batch No: PA2128L available in the Nigerian market was a counterfeit, as determined by the investigation carried out and observations made on the product.
“The genuine Aflotin 20/120 tablet is a combination of Artemether/Lumefantrine (20mg/120mg) and is primarily used for the treatment of uncomplicated malaria caused by the Plasmodium falciparum parasite,” it said.
The regulatory agency emphasised that counterfeit medicines endanger people’s health because they do not comply with regulatory standards, which meant the safety, quality, and efficacy of these products are not ensured.
“The use of counterfeit medicines often fail to treat diseases or conditions effectively, leading to serious health consequences, including death,” NAFDAC said.
It said all NAFDAC zonal directors and state coordinators had been informed and directed to conduct surveillance and remove any counterfeit products found within their zones and states.
NAFDAC also advised distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance within the supply chain to avoid the distribution, sale, and use of counterfeit products.
It advised that all medical products must be obtained from authorised/licensed suppliers.
