The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide warning to healthcare professionals and the public after counterfeit batches of Mabthera 500mg/50ml were confirmed in circulation. The alert follows reports from Roche Nigeria identifying fake products in Kaduna and Gombe states, bearing batch number N2110A09.
Mabthera, generically known as rituximab, is a critical antibody used to treat blood cancers, including non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia, as well as autoimmune diseases such as rheumatoid arthritis, pemphigus vulgaris, and vasculitis. The drug works by targeting and eliminating harmful B-cells in the body. The counterfeit batches were reportedly sold at unusually low prices ranging from NGN 160,000 to NGN 275,000, well below market rates.
Roche Nigeria’s investigation revealed major discrepancies in packaging and vials, including incorrect batch numbers, language errors, misplacement of Braille text, and non-standard tamper-evident labels. Physical differences in vial design, stopper, aluminum seal, and flip-off cap further confirmed deliberate counterfeiting. Due to the lack of physical samples, analysis relied on photographic evidence provided by healthcare professionals.
NAFDAC stressed that genuine Mabthera 500mg/50ml is manufactured for F. Hoffmann-La Roche Ltd in Basel, Switzerland, and produced by Roche Diagnostics GmbH in Mannheim, Germany. The agency warned that the counterfeit products pose serious risks to patient safety and urged medical practitioners to verify the authenticity of all oncology and specialty medications before administration.
The agency also called on the public and healthcare providers to remain vigilant and report suspected counterfeit or substandard medicines. Reports can be made at the nearest NAFDAC office, via the toll-free line 0800-162-3322, or through email at sf.alert@nafdac.gov.ng. “Protecting public health is a shared responsibility,” NAFDAC stated, urging stakeholders to act swiftly to prevent the distribution and use of falsified medicines.
