The National Agency for Food and Drugs Administration and Control (NAFDAC) informs the public of the illegal distribution and marketing of a substandard and falsified anti-malaria, Colamar (Artemether/Lumefantrine 20/120mg).
The Substandard and falsified product is a pass-off of Lonart Suspension and has a fake NAFDAC Registration Number (NRN): B4-4065 which is a registration number of Malasyn Tablets (Dihydroartemisinin 40Mg, Piperaquine Phosphate 320Mg Tablets) which is the Company’s product whose certificate expired on 22/12/2019.
Artemether/Lumefantrine 20/120mg is an antimalarial medication used to treat acute uncomplicated malaria caused by Plasmodium falciparum.
Risk Statement
The illegal marketing of medicines or counterfeit medicines poses a risk to people’s health, since by not complying with the regulatory provisions, the products’ safety, quality, and efficacy are not guaranteed.
Product details
The details of the product are as follows.
Product Name: Colamar 20/120 Powder for Oral Suspension
Stated Active Ingredients: Artemether/Lumefantrine 20/120mg
Batch Number: ALD2424
Manufacturing date: 02/2024
Expiry date: 01/2027
Stated NRN: B4-4065
Name and Address of Manufacturer: Archy Pharm. Nig Ltd., 30 Win Funke Street, Lagos-Abeokuta Expressway, Ojokoro- Lagos, Nigeria.
Please note that the above NRN (NAFDAC Registration Number) is falsified.
Product picture
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard and falsified 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 the substandard and falsified product. 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!!!
