The National Food and Drug Administration and Control (NAFDAC) has issued a critical public alert regarding counterfeit Mabthera 500mg/50ml with batch number N7458B07 currently circulating in Nigeria.
This announcement, categorized as Public Alert No. 037/2024, follows reports from the marketing authorization holder, Roche, which were triggered by a patient’s inquiry into the authenticity of the product.
In a statement released by NAFDAC, it was revealed that discrepancies were noted between the counterfeit product and the genuine Mabthera distributed by Roche in Nigeria. Roche’s investigation, which included a comparison of the complaint sample with a retained sample in Turkey, confirmed that the genuine Mabthera batch N7458B07 was distributed to Turkey in February 2021, expired in November 2022, and was never shipped to Nigeria.
Significant differences were observed in the counterfeit product’s packaging. According to NAFDAC, “The folding boxes and the Tamper Evident labels do not correspond to genuine Roche MabThera packaging material. The English text printed on the packaging appears to be an automatic translation from Turkish to English.” These inconsistencies indicate that the counterfeit product is not only visually different but may also lack the required safety and efficacy standards.
MabThera, a drug used for treating various forms of non-Hodgkin’s lymphoma in children and adolescents, including CD20 positive diffuse large B-cell lymphoma (DLBCL) and Burkitt lymphoma (BL), is particularly vulnerable to counterfeit risks due to its high demand. The safety and effectiveness of such counterfeit medicines cannot be assured, posing significant health risks to patients.
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Roche’s statement also noted that chemical analysis of the counterfeit product was not feasible as only pictures of the packaging, not the vials or leaflets, were available. This limitation further underscores the challenge of identifying and addressing counterfeit medicines.
NAFDAC has urged healthcare professionals and the public to report any suspected substandard or falsified medicines. Concerns should be directed to the nearest NAFDAC office, or reported through the hotline at 0800-162-3322 or via email at sf.alert@nafdac.gov.ng.
In response to the alert, NAFDAC emphasizes the critical need for vigilance in the fight against counterfeit drugs, stressing that such products not only undermine public trust in medical treatments but also pose severe health risks due to their unverified quality and safety standards.
