The National Agency for Food and Drug Administration and Control has raised an alarm over a batch of counterfeit Artemether/Lumefantrine tablets that is currently circulating under the brand name Aflotin 20/120 across Nigeria.
NAFDAC made the notification in a statement via its website.
The statement disclosed that the counterfeit product was discovered and reported to the agency by the genuine manufacturer, Ajanta Pharma Limited, Mumbai, India.
“According to Ajanta Pharma, the following observations were made on the counterfeit product.
“The batch number PA2128L was manufactured by Ajanta Pharma in December 2018, with an expiry date of November 2020. This batch was created for Combisunate 20/120 (Artemether 20mg/Lumefantrine 120mg tablets), with a pack size of 30 x 24 tablets, which is now being counterfeited and sold as Aflotin 20/120mg with a pack size of 1 x 18 tablets.”
The agency further noted that the overprinted matter and text on the carton of the counterfeit Aflotin 20/120mg artwork did not match Ajanta’s overprinting style and approved artwork.
The agency further noted that the overprinted matter and text on the carton of the counterfeit Aflotin 20/120mg artwork did not match Ajanta’s overprinting style and approved artwork.
“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 thePlasmodium falciparumparasite,” the statement further read.
Furthermore, NAFDAC emphasised that counterfeit or falsified medicines endangered people’s health because they did not comply with regulatory standards, which means the safety, quality, and efficacy of these products were not ensured.
Consequently, the use of counterfeit medicines often fails to treat diseases or conditions effectively, leading to serious health consequences, including death.
The drug control agency listed the details of the counterfeit product as:
“Product Name: AFLOTIN 20/120mg (Artemether 20mg/Lumefantrine 120mg); Batch No: PA2128L; Mfg. Date: 04/2023; Exp. Date: 03/2026; Stated Manufacturer: Ajanta Pharma Limited, Mumbai, India.
“Stated Manufacturer Address: B-4/5/6, MIDC Industrial Area, Paithan, 431 148. Read/Corp. Off/Bureau, Ajanta House, Charkop, Kandivli (W), Mumbai 400 067.”
Against this backdrop, “All NAFDAC zonal directors and state coordinators have been informed and directed to conduct surveillance and remove any counterfeit products found within their zones and states, the statement added.
“Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng.”