The National Agency for Food and Drugs Administration and Control (NAFDAC) is writing to inform the public about the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in the country. The product is manufactured by Strides Arcolab Limited, based in India.
This product was discovered in the FCT and Rivers State, during surveillance activities conducted by officers of the Post Marketing Surveillance Directorate of NAFDAC.
The Laboratory report of the analysis carried out on the product revealed that it contained Zero APIs. The product was also observed to have two different date markings. The NAFDAC database of registered products has confirmed that the product license has expired and the NAFDAC Registration Number on it is wrong and not for the product.
COMBIART (Artemether + Lumefantrine 20/120mg) The Artemether and Lumefantrine combination belongs to a group of medicines known as antimalarials. It treats malaria, a red blood cell infection transmitted by the bite of a mosquito. However, this medicine is not used to treat severe or complicated malaria.
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 effectively treat diseases or conditions, leading to serious health consequences, including death.
Product details
The details of the product are as follows:
Brand Name: Combiart Dispersible Tablet 20/120mg
Generic Name: Artemether + Lumefantrine 20/120mg Dispersible Tablet
Batch No: 7225119
NAFDAC Reg No: A11-0299
Manufacturing Date: June 2023 and Feb 2023
Expiry Date: May 2026 and June 2026
Manufacturer’s Name and Address: Strides Arcolab Limited, 36/7, Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bangalore- 562 106, India.
Product picture
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit products within the zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, 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 or medical devices 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!!!
