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NAFDAC Alerts Public to Confirmed Counterfeit Mabthera 500mg/50ml in Nigeria

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By Bunmi Yekini

The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public warning regarding the discovery of counterfeit Mabthera 500mg/50ml, a medication used for treating certain types of lymphoma, with batch number N7458B07 in Nigeria. This alert comes after a patient inquiry led to the detection of discrepancies in the product packaging, raising concerns about its authenticity.

According to NAFDAC, the Marketing Authorization Holder (MAH), Roche, confirmed that the original batch of Mabthera 500mg/50ml was distributed to Turkey in February 2021 and had expired by November 2022. Roche’s investigation revealed significant differences between the counterfeit product found in Nigeria and the genuine product. “The folding boxes and the Tamper Evident labels do not correspond to genuine Roche MabThera packaging material,” the agency noted. it was also observed that “the English text printed on the packaging material seems to be an automatic translation from Turkish to English.”

NAFDAC has urged healthcare providers, importers, distributors, and the public to remain vigilant. “All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked,” NAFDAC advised.

The agency also emphasized the risk posed by counterfeit drugs, stating, “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.”

NAFDAC has directed its zonal directors and state coordinators to conduct surveillance and remove the counterfeit product from circulation. Healthcare professionals and consumers are encouraged to report any suspicion of substandard or falsified medicines to the nearest NAFDAC office or via the agency’s reporting platforms.

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