The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians about the sale of an unauthorised and unregistered brand of Daratumumab (Darzalex), a medicine used to treat multiple myeloma — a type of blood cancer that affects plasma cells.
According to NAFDAC, the fake version of the drug is being sold in some parts of the country without approval from the agency. An internal investigation by Johnson & Johnson, the original manufacturer of Darzalex, revealed that two packaging designs of the product exist — one meant for India and the other for the Arab market.
The company found that the product being circulated in Nigeria did not come from authorised distributors and might have been smuggled into the country.
The identified version meant for India was listed as follows:
- Product Name: Darzalex (Daratumumab) 1800mg/15ml vial for SC Injection
- Batch Number: PKS1F01
- Expiry Date: 10-2026
For the batch intended for the Arab market, the lot number could not be confirmed from the pictures received by Johnson & Johnson.
NAFDAC also emphasised that Darzalex is a cold-chain product, meaning it must be stored at a specific temperature to remain effective. The agency noted that the medicine is not registered for sale in Nigeria, and the quantity of the fake product currently in circulation cannot be determined.
NAFDAC warned that purchasing drugs from unregistered or unauthorised sellers can expose people to counterfeit medicines that may be tampered with, contaminated, stolen, or recalled.
Such fake medicines can lead to treatment failure, serious health complications, or even death.
“Products from unverified sources may not meet safety or quality standards. They could be fake, expired, or not properly stored,” NAFDAC said.
The agency has directed all zonal directors and state coordinators to begin market surveillance and mop-up operations to remove the unauthorised Darzalex products from circulation.
NAFDAC also advised importers, distributors, retailers, healthcare professionals, and caregivers to remain vigilant and ensure that all medical products are purchased only from licensed and verified suppliers.
They were urged to check the authenticity and packaging of all products before use or sale.
How to Report Fake or Unsafe Medicines
NAFDAC called on healthcare professionals and consumers to report any suspected cases of substandard or falsified medicines to the nearest NAFDAC office or through the following channels:
- Phone: 0800-162-3322
- Email: sf.alert@nafdac.gov.ng
- Website: www.nafdac.gov.ng
- Med-Safety App: Available for download on Android and iOS stores
- Email for adverse drug reactions: pharmacovigilance@nafdac.gov.ng
Reports received will also be shared with the World Health Organisation (WHO) Global Surveillance and Monitoring System (GSMS) to help prevent the spread of fake medicines globally.
The agency reaffirmed its commitment to protecting public health and ensuring that only safe, quality, and effective medicines are available in Nigeria.
“We urge Nigerians to always buy drugs from verified pharmacies and avoid unregistered online or street vendors,” NAFDAC stated.
NAFDAC — Customer-Focused, Agency-Minded!
