The National Food and Drug Administration Control (NAFDAC), has notified healthcare providers and the public of the counterfeit Mabthera 500mg/50ml with batch number N7458B07 currently in circulation in Nigeria.
NAFDAC, in a release categorised as a Public Alert No. 037/2024. Alert, confirmed the circulation of the pharmaceutical product in Nigeria, noting that the marketing authorisation holder, Roche received a call from a patient to enquire about the genuineness of the product before purchasing it.
According to the statement, it was discovered that the product pack had discrepancies from the Mabthera distributed by Roche in Nigeria.
“Roche investigated the complaint sample picture and displayed complaint samples that were compared to a batch corresponding with a retained sample in the Turkish makeup presentation.
“It was confirmed the genuine product of Mabthera vials 500mg/50ml, batch number N7458B07 was distributed by Roche to Turkiye in February 2021 which expired in November 2022 and was never shipped into Nigeria.
Significant differences were also found regarding the packaging material.
“The folding boxes and the Tamper Evident labels do not correspond to genuine Roche MabThera packaging material. The English text printed on the packaging material seems to be an automatic translation from Turkish to English (e.g. with the use of a translation tool).”
The statement further read, “MabThera can be used for the treatment of children and adolescents, 6 months of age and older, with non-Hodgkin’s lymphoma, specifically CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukemia (mature B-cell acute leukemia) (BAL) or Burkitt-like lymphoma (BLL).”
Meanwhile, 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 0800-162-3322, or send an email to sf.alert@nafdac.gov.ng
