Nigerian Public Alert 61: NAFDAC Notifies on Confirmed Counterfeits PHESGO 600mg With Batch Numbers B2346B16 and C3809C5

Nigerian Public Alert 61: The Marketing Authorization Holder (MAH), Roche, received these complaints from Lagos University Teaching Hospital (LUTH-NSIA) reporting suspected counterfeit Phesgo® 600mg with batch numbers B2346B16 and C3809C5. The batch C3809C5 vial volume was observed to be approximately 20mL instead of the expected 10mL. Both products were reported to be brought in by patients for administration.

Only pictures of the complaint samples were sent to Roche by the complainants for investigation. Although a complete investigation was not possible, the pictures provided were scrutinized by Roche and compared to genuine retained samples. The investigation identified the following significant differences between the complaint sample pictures and the genuine materials, which confirmed the falsified status of the suspected counterfeit batches

of Phesgo® 600mg;

• A non-existent batch number in their database,
• Incorrect text
• Incorrect variable data
• The GTIN does not correspond to any genuine GTIN
• The tamper-evidence label was missing
• Significant differences in packaging material compared to the genuine product.

Chemical analyses were not possible because physical samples were returned to Roche.

The batch number B2346B16 has been reported in four confirmed counterfeit complaints from multiple countries, including Turkey, Nigeria, and the Philippines. Each complaint featured the same fake batch number and false information as previously described.

Phesgo 600mg is used to treat breast cancer. It works by killing the cancer cells and preventing their further growth.

Risk Statement

The illegal marketing and distribution of counterfeit medicines risks people’s health, as they do not guarantee the safety, quality, and efficacy of the products due to non-compliance with regulatory standards.

Product details

The details of the counterfeit product are as follows:

Note: The correct manufacturing site for genuine Phesgo 600mg/600mg is F.Hoffman La Roche Limited, Wurmisweg, CH-4303, Kaiseraugst, Switzerland.

Product photo

All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit products 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 products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

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, or call NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng

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