The National Agency for Food and Drugs Administration and Control (NAFDAC), has warned healthcare providers and the public about counterfeit Phesgo® 600mg/600mg/10ml.
This suspected counterfeit bears the batch number C5290S20.
Roche, the Marketing Authorization Holder (MAH), acted swiftly after a doctor from Lagos University Teaching Hospital (LUTH-NSIA) reported concerns about the product.
They investigated the complaint to ensure patient safety and product integrity.
A patient presented the product for administration but opted not to use it. This decision arose from its similarity to the previously reported counterfeit batch, C3809C51.
Roche examined images of the suspected product, although no physical sample was returned for further investigation.
The pictures displayed parts of a Phesgo® 600mg/600mg in a 10ml folding box and a labeled vial.
Roche compared these images to genuine samples and identified significant differences, confirming the counterfeit status of the batch.
The investigation revealed discrepancies such as a non-existent batch number in Roche’s database, incorrect associated language, missing Basilisk, incorrect bollino date, and tamper evidence labels that did not match genuine Roche materials.
Chemical analysis was not possible due to the lack of a physical sample.
Phesgo® 600mg/600mg Solution for Injection treats breast cancer effectively. By targeting and killing cancer cells, it prevents their growth.
The illegal marketing of counterfeit medicines poses serious health risks, undermining the safety, quality, and effectiveness of these products.
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NAFDAC, through their official page on X (formerly Twitter), has directed all zonal directors and state coordinators to conduct surveillance and remove counterfeit products within their zones and states.
It warned importers, distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance to prevent counterfeit products within the supply chain.
“To ensure safety, always obtain medical products from authorized suppliers.
“Additionally, carefully check their authenticity and physical condition before using them.
“Healthcare professionals and consumers should report any suspicions of substandard or falsified medicines or medical devices directly to the nearest NAFDAC office.
“For assistance, please call 0800-162-3322 or email sf.alert@nafdac.gov.ng. Your inquiries are welcome.
“Furthermore, report any adverse events or side effects related to medicinal products or devices through NAFDAC‘s E-reporting platforms.
“Use the Med-safety application, available for Android and iOS, or email pharmacovigilance@nafdac.gov.ng for additional assistance”, the agency said in a statement.
Finally, NAFDAC assured that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS) to initiate further action.
