The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers, importers, distributors, retailers, Patent and Proprietary Medicine Vendors (PPMVs), and the general public of the seizure of a suspected Substandard and Falsified (SF) antimalarial medicine, Artemether/Lumefantrine 80mg/480mg, purportedly manufactured by Bandaram Pharma Packleh Ltd (BPPL), India.
The product was intercepted by NAFDAC officials during routine Post-Market Surveillance activities at the Coordinated Wholesale Centre (CWC), Kano State. Verification conducted by NAFDAC confirmed that the NAFDAC Registration Number 02-3457 displayed on the product is fake and does not exist in the Agency’s registration database.
The product label does not indicate the MAH information.
Given that Artemether/Lumefantrine is used in the treatment of malaria, the circulation and use of falsified products may result in treatment failure, worsening of disease, development of drug resistance, and other serious public health consequences. The product has therefore been classified as a Falsified (F) Medical Product.
Product Details
Product Information | Details |
Product Name | Artemether/Lumefantrine 80mg/480mg |
Purported Manufacturer | Bandaram Pharma Packleh Ltd (BPPL) |
Manufacturer’s Address | Plot No. 1 & 2, Number 13, Mirgila, Nagar, India |
NAFDAC Registration Number | 02-3457 (Fake) |
Batch Number | BP5203 |
Manufacturing Date | 10/2024 |
Expiry Date | 09/2027 |
Marketing Authorisation Holder (MAH) | Not declared on the product label |
Product Photo
Fig: Front, Back and Side view of the secondary package
NAFDAC remains committed to safeguarding public health through continuous surveillance and regulatory actions aimed at preventing the circulation of substandard and falsified medical products in Nigeria.
Advice to Healthcare Professionals and the Public
Healthcare professionals and members of the public are advised to:
- Exercise caution and avoid the purchase, sale, supply, or use of the affected product.
- Obtain medicines only from authorised and licensed suppliers.
- Carefully check the authenticity of medicines before purchase and use.
- Report any suspected sale, distribution, or use of the product to the nearest NAFDAC office.
Reporting of Adverse Events
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, call 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
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@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!!!
