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The National Agency for Food and Drugs Administration and Control (NAFDAC) has drawn the attention of the general public, especially healthcare providers, to a counterfeited medicine that puts children’s health at risk.
TheNewsGuru.com (TNG) reports the medicine known as Mabthera is originally used for the treatment of children and adolescents, 6 months of age and older, with non-Hodgkin’s lymphoma.
However, it has been confirmed that 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.
The Marketing Authorization Holder (MAH), Roche received a call from a patient to enquire about the genuineness of the product before purchasing it. The product pack was observed to have some discrepancies from the Mabthera distributed by Roche in Nigeria.
Roche further investigated the complaint sample picture. The displayed complaint samples were compared to a batch corresponding with a retain sample in Turkish make-up presentation. It was then confirmed that 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 found regarding the displayed 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).
According to NAFDAC, however, chemical analysis was not possible, as the physical complaint sample was not provided for investigation, Roche only received pictures displaying parts of the Mabthera 500mg/50ml pack, with batch number N7458B07. No pictures of vials and leaflets were available.
“The illegal promotion or sale of counterfeit medicines puts people’s health at risk as it does not ensure the safety, quality, and effectiveness of the products.
“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 product.
“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked,” NAFDAC stated.
