The National Agency for Food and Drug Administration and Control has alerted healthcare professionals and the public to the circulation of a confirmed counterfeit batch of Mabthera 500mg/50ml in Nigeria.
The agency said the alert followed official communication from Roche Nigeria, which reported the discovery of fake versions of the drug with batch number N2110A09 in Kaduna and Gombe states.
According to findings by the Marketing Authorization Holder, complaints were received from healthcare professionals in both states after patients presented the suspected counterfeit product, which had been purchased at unusually low prices ranging between N160,000 and N275,000.
Investigations by Roche Nigeria revealed multiple discrepancies in the packaging of the counterfeit product. The batch number was found to be non-existent in the company’s database, while the packaging featured the wrong language, with Turkish used instead of English. There were also errors in the placement of Braille text and inconsistencies in tamper-evidence labels.
Further examination identified significant differences in the vial itself, including a non-existent batch number, incorrect language usage, variations in the shape and dimensions of the glass vial, and differences in the stopper, aluminium seal and flip-off cap.
The agency noted that chemical analysis could not be conducted as no physical samples were available, with the investigation relying solely on photographs provided by complainants.
Mabthera, also known as rituximab, is a critical antibody injection used in the treatment of blood cancers such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia. It is also prescribed for severe rheumatoid arthritis and autoimmune conditions, including pemphigus vulgaris and vasculitis, by targeting and destroying specific white blood cells responsible for disease progression.
NAFDAC warned that counterfeit oncology medicines pose serious health risks, as they may contain incorrect or no active ingredients, harmful substances, or improper dosage levels. Such defects could lead to treatment failure, worsening of disease, severe adverse reactions, or death.
Details released by the agency indicate that the counterfeit product falsely listed its place of production as Genentech Inc., Hillsboro, while bearing the batch number N2110A09 and an expiry date of October 9, 2026. The genuine product, however, is manufactured for F. Hoffmann-La Roche Ltd in Basel, Switzerland, by Roche Diagnostics GmbH in Mannheim, Germany.
In response to the discovery, NAFDAC has directed all zonal directors and state coordinators to intensify surveillance and remove the counterfeit products from circulation across affected areas.
The agency also urged importers, distributors, retailers, healthcare providers and caregivers to remain vigilant within the supply chain, stressing that all medical products must be sourced from authorised and licensed suppliers.
It advised that the authenticity and physical condition of medicines should always be carefully verified before use, adding that any suspected cases of substandard or falsified drugs should be promptly reported to the nearest NAFDAC office.
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