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NAFDAC Seizes Falsified Artemether/Lumefantrine Antimalarial in Kano

Following the seizure of a suspected falsified Artemether/Lumefantrine 80mg/480mg, purportedly manufactured by Bandaram Pharma Packleh Ltd (BPPL), India, the National Agency for Food and Drug Administration and Control (NAFDAC) through a post on its website has warned healthcare professionals, importers, distributors, retailers, PPMVs and the public against its purchase or use.

According to the regulatory agency, NAFDAC, the said product was intercepted during routine Post-Market Surveillance activities at the Coordinated Wholesale Centre (CWC) in Kano State.

According to NAFDAC, verification of the product revealed that the NAFDAC Registration Number 02-3457 displayed on the packaging is fake and does not exist in the Agency’s registration database.

The product label also does not declare a Marketing Authorisation Holder (MAH) information.

The affected medicine is:

Product detailInformation
ProductArtemether/Lumefantrine 80mg/480mg
Purported manufacturerBandaram Pharma Packleh Ltd (BPPL)
Purported addressPlot No. 1 & 2, Number 13, Mirgila, Nagar, India
NAFDAC Registration No.02-3457 — Fake
Batch numberBP5203
Manufacturing dateOctober 2024
Expiry dateSeptember 2027
Marketing Authorisation HolderNot declared on the label

NAFDAC has classified the product as a Falsified (F) Medical Product.

Why is this concerning?

Artemether/Lumefantrine is a very important antimalarial medicine used in the treatment of malaria, and the use of a falsified artemether/Lumefantrine can lead to treatment failure, increased risk of antimalarial drug resistance, or even jeopardize patients’ safety.

Note that the presence of a purported registration number on a medicine’s packaging should therefore not be taken as proof of authenticity, particularly when the number has not been issued by the regulatory authority.

NAFDAC’s advice

Healthcare professionals, medicine vendors, distributors and members of the public to:

  • Apply caution and avoid purchasing, selling, supplying or using the affected product.
  • Obtain medicines only from authorised and licensed suppliers.
  • Always check the authenticity of medicines before purchase and use.
  • Report suspected sales or distribution of the product to the nearest NAFDAC office.

How to report suspected falsified medicines

Reports of suspected sales, distribution or use of the falsified medicines can be made to NAFDAC through:

NAFDAC toll-free line: 0800-162-3322
SF Alert: sf.alert@nafdac.gov.ng

Furthermore, reports of adverse events or suspected side effects associated with medicinal products or devices can also be made 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 concerning NAFDAC reforms, the Agency has provided the following contacts:

Phone: 09097630506, 09097630507
Email: reforms@nafdac.gov.ng

NAFDAC stated that the notice will also be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).

What should patients do?

If you have recently purchased or received Artemether/Lumefantrine 80mg/480mg with batch number BP5203 and NAFDAC registration number 02-3457, do not use it until its authenticity has been confirmed.

Speak with a pharmacist or other qualified healthcare professional if you are unsure about the authenticity of an antimalarial medicine or need an alternative treatment.

Health Amebo recommends that medicines should always be purchased from licensed pharmacies or other authorised medicine outlets.

Source: National Agency for Food and Drug Administration and Control (NAFDAC), Public Alert No. 042/2026-Alert on the Seizure of Suspected Substandard and Falsified BPPL Artemether/Lumefantrine 80mg/480mg – NAFDAC