The National Agency for Food and Drugs Administration and Control (NAFDAC) has sent an alert to the public and especially healthcare providers of a suspected counterfeit cancer treatment drug, Phesgo® 600mg/600mg/10ml, labeled with batch C5290S20, calling on stakeholders to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of counterfeit products.
According to the Agency, the Marketing Authorization Holder (MAH) Roche received a complaint from a doctor at Lagos University Teaching Hospital (LUTH-NSIA) reporting a suspected counterfeit Phesgo® 600mg/600mg, labeled with batch C5290S20, which was reported to have been brought in by a patient for administration.
At the time of the report, it had not been administered as it matched the previously reported counterfeit batch C3809C5, NAFDAC added
According to NAFDAC, although no sample was returned to Roche for investigation, only pictures displaying parts of a Phesgo® 600mg/600mg in a 10ml folding box and a labeled vial, and images of the suspected product were examined by Roche and compared to the genuine samples retained for reference.
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 batch of Phesgo® 600mg/600mg.
- A non-existent batch number in their database,
- Associated language does not correspond,
- Missing Basilisk, incorrect bollino date, and
- The tamper evidence labels do not correspond to the genuine Roche material.
According to NAFDAC, Chemical analysis was not possible because no physical sample was available for return to Roche.
Phesgo 600mg/600mg Solution for Injection is used to treat breast cancer. It works by killing the cancer cells and preventing their further growth.
The regulatory agency stated that the illegal marketing of counterfeit medicines poses serious health risks, as it undermines the safety, quality, and effectiveness of these products due to a lack of regulatory compliance provisions.
In an effort to stop this fake product from circulating, NAFDAC said it has directed all NAFDAC zonal directors and state coordinators to carry out surveillance and mop up of the counterfeit products within the zones and state.
Product details
The details of the counterfeit product are as follows:
Product Name: Phesgo® 600mg/600mg/10ml injection
Stated Manufacturer: Roche
Manufacturing Date: 01/2024
Expiry Date: 01/2026
Batch No: C5290S20
Manufacturing site of the counterfeit product is Roche S, P.A
Note: The correct manufacturing site for genuine Phesgo 600mg/600mg is F.Hoffman La Roche Limited, Wurmisweg, CH-4303, Kaiseraugst, Switzerland.
