The National Agency for Food and Drugs Administration and Control (NAFDAC) is alerting the public on the sale of an unauthorized and unregistered brand of Daratumumab formulation in Nigeria.
An internal investigation conducted by Johnson & Johnson revealed that there are two different packaging designs for their Daratumumab product. One design is intended for the Indian market, while the other is meant for the Arab market.
The India Lot was identified as below
Product Name | Batch Number | Expiry Date |
Darzalex (Daratumumab) 1800mg/15 ml vial for SC Injection | PKS1F01 | 10-2026 |
For the Product destined for Arab Markets, the Lot number could not be identified from the pictures received.
Darzalex is the brand name for daratumumab, a prescription medicine used for the treatment of multiple myeloma (a type of blood cancer affecting plasma cells).
To note that:
- Darzalex is a cold-chain product and is not registered in Nigeria.
- The exact quantity available in the market cannot be estimated
- The product was not purchased from the authorized and official distributors of the Johnson & Johnson company in Nigeria
Risk Statement
Purchasing pharmaceutical products from unauthorized/unregistered sources may result in the introduction of counterfeit products that have been tampered with, stolen goods, products intended to be recalled from the market, or products not cleared by local regulatory authorities.
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All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the unauthorized/unregistered product within the zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance within the supply chain to prevent the importation, distribution, sale, and use of the unauthorized/unregistered 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!!!
