The National Agency for Food and Drug Administration and Control, NAFDAC, yesterday issued a nationwide alert to healthcare professionals and the public following the confirmation of counterfeit batches of Mabthera 500mg/50ml in circulation.
The warning comes after official communication from Roche Nigeria, which identified counterfeit cases bearing batch number N2110A09 in Kaduna State and Gombe State.
Mabthera, known generically as rituximab, is a critical antibody injection used in the treatment of 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.
According to the Marketing Authorisation Holder, the counterfeit batch was discovered following complaints from healthcare professionals in the affected states. "In both reported cases, the suspected counterfeit product was brought into healthcare facilities by patients who had purchased them at unusually low prices," the agency stated.
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The products were reportedly sold between NGN 160,000 and NGN 275,000, well below the standard market range.
Roche Nigeria's investigation found "clear and alarming discrepancies" in the product packaging. The company confirmed that the batch number does not exist in its official database. It also identified the use of the wrong language on packaging, incorrect placement of Braille text, and tamper-evidence labels that do not meet genuine product standards.
Further irregularities were observed on the vial itself. Investigators noted inconsistencies in the batch number, language usage, and physical characteristics of the vial, including differences in shape, dimensions, stopper design, aluminium seal, and flip-off cap.
"These variations strongly indicate deliberate counterfeiting activity," Roche Nigeria said.
Due to the absence of physical samples, chemical analysis could not be conducted. The investigation relied on photographic evidence submitted by complainants.
NAFDAC emphasized that genuine Mabthera 500mg/50ml is manufactured for F. Hoffmann-La Roche Ltd in Basel, Switzerland, and produced by Roche Diagnostics GmbH at its Galenical Plant in Mannheim, Germany.
"This development poses a serious risk to patient safety," NAFDAC warned.
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"Healthcare providers must exercise extreme caution and verify the authenticity of all oncology and specialty medicines before administration."
The agency urged healthcare professionals and members of the public to remain vigilant and report any suspected cases of counterfeit or substandard medicines. Reports can be made at the nearest NAFDAC office, via the toll-free number 0800-162-3322, or by email at [email protected].
"Protecting public health is a shared responsibility. We call on all stakeholders to act swiftly and responsibly in preventing the distribution and use of falsified medicines," NAFDAC stated.
