The National Agency for Food and Drug Administration and Control (NAFDAC) warns the public against counterfeit cancer drugs Phesgo® 600mg and Avastin 400mg/16ml currently circulating in Nigeria.
In a statement shared on its official X handle on Thursday, NAFDAC alerted healthcare providers and the public about the discovery of suspected counterfeit Phesgo® 600mg/600mg/10ml in Lagos, labeled with batch C5290S20.
The alert also highlighted the detection of counterfeit Avastin 400mg/16ml in Kano and Abuja, involving batches H0223B08 and H4239A70.
Phesgo® 600mg counterfeit details
According to NAFDAC, the Marketing Authorization Holder (MAH) Roche received a complaint from a doctor at Lagos University Teaching Hospital (LUTH-NSIA).
- The report indicated that a patient brought in the suspected counterfeit Phesgo® 600mg/600mg, labeled with batch C5290S20 for administration, though It had not been administered at the time of the report.
- NAFDAC noted that the suspected counterfeit batch matched the previously reported counterfeit batch C3809C51.
- Although no sample was returned to Roche for investigation, the agency received only pictures displaying parts of a Phesgo® 600mg/600mg in a 10ml folding box and a labeled vial.
“Images of the suspected product were examined by Roche and compared to the genuine samples retained for reference,” the agency noted.
- 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.
- According to NAFDAC, the counterfeit batch was found to have, 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.
- However, due to the absence of a sample, the agency said 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 agency emphasized the risks of counterfeit drugs, warning 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.
Details of the counterfeit product:
- 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
The correct manufacturing site for genuine Phesgo 600mg/600mg is F.Hoffman La Roche Limited, Wurmisweg, CH-4303, Kaiseraugst, Switzerland.
Avastin 400mg counterfeit details
NAFDAC also raised concerns about counterfeit Avastin 400mg/16ml discovered in Kano and Abuja. Two counterfeit batches, H0223B08 and H4239A70, were identified.
- The first case involved batch H0223B08, reported by a pharmacist after a patient purchased counterfeit vials from a pharmacy in Kano.
- NAFDAC noted that batch H0223B08 had been mentioned in an earlier public alert.
- Another report of counterfeit Avastin 400mg/16ml, batch H4239A70, was flagged by a pharmacist at the Federal Medical Center in Abuja.
- NAFDAC’s investigation confirmed that the genuine batch number H0223B08 is associated with Avastin 400mg/16ml in Vietnamese make-up, the genuine product was distributed to Vietnam in July 2020, and the batch H0223B08 already expired in July 2022.
The agency also revealed that no batch tracing was possible for Avastin 400mg/16ml with batch no H4239A70 as this is not a genuine Roche product and the batch number doesn’t exist in their database.
Avastin 400mg Injection is an anticancer medication. It is used in the treatment of cancer of the colon and rectum, non-small cell lung cancer, kidney cancer, brain tumor, ovarian and cervical cancer. It helps to prevent the growth of new blood vessels that feed tumors and stops tumors from growing, NAFDAC explained.
Details of the counterfeit batches
- Batch H0223B08: Manufactured in May 2023, expired July 2026.
- Batch H4239A70: Manufactured in March 2024, expired October 2026.
The correct manufacturing site for genuine Avastin vial 400mg/16ml is Roche Diagnostics GmbH, Sandhofer Strasse 11668305, Mannheim, Germany.
NAFDAC urges vigilance in the supply chain
NAFDAC calls on importers, distributors, retailers, and consumers to exercise caution and vigilance to avoid the importation, distribution, sale, and use of counterfeit Avastin.
The agency advised that all medical products must be obtained only from authorized or licensed suppliers, and their authenticity and physical condition should be thoroughly verified.
“Anyone in possession of any of the counterfeit lots is advised to immediately discontinue sale or use and submit stock to the nearest NAFDAC office.
“If you have used any of the products, or someone you know, has used it, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional,” NAFDAC cautions.
Reporting suspicious products and adverse events
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
