Nigerian Public Alert 63: The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare professionals and the public of a confirmed counterfeit batch of Mabthera 500mg/50ml circulating in Nigeria. This alert follows official communications from Roche Nigeria confirming counterfeit cases of Mabthera 500mg/50ml with batch number N2110A09 reported in Kaduna and Gombe states of Nigeria.
According to the Marketing Authorization Holder (MAH), the report of a counterfeit batch of Mabthera 500mg/50ml was received as complaints from healthcare professionals in both locations mentioned above. In both cases, the counterfeited batch of the product was brought in by patients in each location and reportedly sold at significantly lower prices between NGN 160,000 and NGN 275,000, respectively.
Roche Nigeria’s investigation revealed clear evidence of counterfeit activities regarding the folding box. The following differences were detected:
- 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.
In addition, several significant differences were detected on the labelled vial, including a non-existent batch number, wrong language (English instead of Turkish), a different glass vial (e.g., shape and dimensions), a different stopper (e.g., colour, dimensions), a different aluminium seal (e.g., dimensions), and a different flip-off cap (e.g., colour, shape).
Chemical analyses were not possible as investigations were conducted based on packaging photographs sent in by complainants; no physical samples were available for return to Roche.
Mabthera (rituximab) is an antibody injection used to treat blood cancers (non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia), severe rheumatoid arthritis, and autoimmune diseases like pemphigus vulgaris and vasculitis. It destroys specific white blood cells (B-cells) that cause disease.
Risk Statement
Counterfeit oncology medicines may contain incorrect or no active ingredients, harmful contaminants, or incorrect dosage strength. This may result in treatment failure, disease progression, serious adverse events, or death
Product details
The details of the counterfeit products are as follows:
| Product Name | Stated Place of Production | Batch Number | Manufacturing Date | Expiry Date |
| Mabthera 500 mg/50 mL | Genentech Inc., Hillsboro, ABD | N2110A09 | Not provided in the pack | 09/10/26 |
Note: The correct manufacturing site for genuine Mabthera 500 mg/50 mL is Made for F. Hoffmann-La Roche Ltd, Basel, Switzerland by Roche Diagnostics GmbH, Galenical Plant, Germany, Sandhofer Strasse 116, Mannheim 68305.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit product within the zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of counterfeit products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
PositiveNaija Nigerian Public Alert
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