NAFDAC warns of fake Mabthera cancer drugs circulating in Northern Nigeria

NIGERIA—Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide alert to healthcare professionals and the public after confirming counterfeit batches of Mabthera 500 mg/50 ml. 

The warning comes after an official report from Roche Nigeria, which traced the fake products bearing batch number N2110A09 in Kaduna and Gombe States.

Mabthera, sold generically as rituximab, is a critical antibody injection that doctors use to treat serious conditions, including blood cancers such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia, as well as autoimmune diseases like rheumatoid arthritis, pemphigus vulgaris, and vasculitis.

The drug works by targeting and destroying harmful B-cells in the body, making its authenticity a matter of life and death for patients.

How the Fakes Were Discovered

Roche Nigeria launched its investigation after healthcare professionals in the affected states raised complaints.

In both reported cases, patients had purchased the drug from unauthorized sources at unusually low prices—between NGN 160,000 and NGN 275,000 (USD 97–USD 167), well below the standard market range.

The investigation uncovered what Roche Nigeria described as “clear and alarming discrepancies” in the product packaging.

The batch number does not exist anywhere in the company’s official database.

Additionally, investigators identified the wrong language on the packaging, incorrectly placed Braille text, and tamper-evidence labels that fall short of genuine product standards.

Irregularities on the Vial

Investigators also identified irregularities on the vial itself.

The batch number, language usage, and several physical characteristics—including the shape, dimensions, stopper design, aluminium seal, and flip-off cap—all differed from those of an authentic product.

Because no physical samples were available for testing, Roche Nigeria based its findings entirely on photographic evidence submitted by complainants.

NAFDAC confirmed that genuine Mabthera 500 mg/50 ml is manufactured for F. Hoffmann-La Roche Ltd. in Basel, Switzerland, and produced by Roche Diagnostics GmbH at its Galenical Plant in Mannheim, Germany.

The agency stressed that this development poses a serious risk to patient safety and urged healthcare providers to verify the authenticity of all oncology and specialty medicines before administering them.

NAFDAC is calling on healthcare professionals and members of the public to report any suspected counterfeit or substandard medicines to the agency immediately.