The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide alert over a confirmed counterfeit batch of Mabthera 500mg/50ml circulating in Nigeria.
This was disclosed in a public notice by the agency, following official communication from Roche Nigeria confirming cases of falsified Mabthera with batch number N2110A09 detected in Kaduna and Gombe states.
Mabthera (rituximab) is an antibody injection used in the treatment of blood cancers such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia, as well as autoimmune conditions including rheumatoid arthritis, pemphigus vulgaris, and vasculitis.
What NAFDAC saying
According to NAFDAC, Roche Nigeria, the Marketing Authorization Holder, received complaints from healthcare providers after the products were brought in by patients who had purchased them at significantly lower prices ranging between N160,000 and N275,000.
Investigations by Roche confirmed clear evidence of counterfeiting, particularly in the product packaging and vial components.
NAFDAC identified key discrepancies in the counterfeit products, including:
- The batch number does not exist in the Roche database.
- Wrong language (Turkish instead of English),
- Wrong placement of Braille text, and
- Incorrect tamper-evidence labels.
The agency added that further differences were observed on the vial, including the use of non-existent batch numbers, incorrect language labelling, noticeable variations in the vial’s shape and dimensions, differences in the stopper’s colour and size, as well as inconsistencies in the aluminium seal and flip-off cap design.
Chemical analysis could not be conducted as investigations were based on packaging photographs submitted by complainants, with no physical samples available.
More insights
Details of the affected counterfeit product:
- Mabthera 500mg/50ml
- Batch number: N2110A09
- Manufacturing date: Not indicated
- Expiry date: October 9, 2026
- Stated place of production: Genentech Inc., Hillsboro
The agency clarified that genuine Mabthera is manufactured for F. Hoffmann-La Roche Ltd, Basel, Switzerland, by Roche Diagnostics GmbH in Mannheim, Germany.
All zonal directors and state coordinators have been directed to intensify surveillance and remove the counterfeit products from circulation.
Importers, distributors, retailers, and healthcare providers were advised to source medicines only from authorized suppliers and verify product authenticity before use.
What you should know
NAFDAC previously warned about other counterfeit cancer medicines in circulation, including Avastin 400mg, batches of Tecentriq 1200mg/20ml across the country and versions of Phesgo 600mg, a drug used in the treatment of breast cancer.
In a recent notice, the agency warned about the recall of MR.7 SUPER 700000 male enhancement capsules after the product was found to contain undeclared pharmaceutical ingredients, posing serious health risks to consumers.
- In another safety alert, NAFDAC recently directed the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across the country.
- The agency also flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.
- Another is on the circulation of falsified Dostinex 0.5mg tablets in Nigeria. The legitimate product is registered but not yet imported, while the fake batches, GG3470, LG8659, and GG2440, have no NAFDAC registration and may be unsafe.
