The National Agency for Food and Drug Administration and Control is notifying the public of the presence of one batch of counterfeit Artemether/Lumefantrine tablets circulating under the brand name Aflotin 20/120 in Nigeria. 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 overprinted matter didn’t match Ajanta’s overprinting style.
- The text on the carton of the counterfeit Aflotin 20/120mg artwork didn’t match Ajanta’s approved artwork.
Ajanta Pharma has confirmed that the Aflotin 20/120mg with Batch No: PA2128L available in the Nigerian market is a counterfeit, as determined by the investigation carried out and observations made on the product.
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.
Risk statement
Counterfeit or falsified medicines endanger people’s health because they do not comply with regulatory standards, which means the safety, quality, and efficacy of these products are not ensured. The use of counterfeit medicines often fails to treat diseases or conditions effectively, leading to serious health consequences, including death.
Product details
The details of the counterfeit product are as follows:
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/ Bereau, Ajanta House Charkop, Kandivill (W) Mumbai 400 067
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.
Distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the distribution, sale, and use of counterfeit products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
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
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
