The National Food and Drug Administration Control (NAFDAC) has raised an alarm among healthcare providers and the public about counterfeit Mabthera 500 mg/50 ml with batch number N7458B07 in circulation, News About Nigeria reports.
According to NAFDAC’s public alert No. 037/2024, the product is currently being sold in Nigeria.
The agency said 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 500 mg/50 ml, batch number N7458B07, was distributed by Roche to Turkiye in February 2021, which expired in November 2022 and was never shipped into Nigeria.
It said that 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 leukaemia (mature B-cell acute leukaemia) (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.
