The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the healthcare providers and the public of a report of confirmed counterfeit Avastin 400mg in Nigeria.
The Marketing Authorization Holder (MAH), Roche, reported that an oncologist from a local hospital expressed concern about potentially counterfeit Avastin vials (400 mg/16 ml), batch numbers K1830T71 and H0375B01.
According to the MAH, the complaint sample was compared to a genuine retain sample in the EFA (English, French, and Arabic) make-up presentation, because the GTIN (Global Trade Item Number) of the complaint sample folding box corresponded to the EFA make-up presentation.
The following differences were observed during investigation
- The batch number does not exist in the Roche database, making lot tracing impossible.
- The artwork contained incorrect text and spelling errors.
- Variable data was incorrect, and the placement was not consistent.
- The Tamper Evidence labels do not correspond to genuine Roche material.
- The complaint sample serial number does not correspond to any genuine Roche serial number.
The findings clearly indicate the presence of counterfeit packaging.
AVASTIN (bevacizumab) is indicated for the treatment of recurrent glioblastoma in adults. It is a tumour-starving (anti-angiogenic) therapy.
Risk Statement
The illegal marketing of medicines or counterfeit medicines poses a risk to people’s health because it does not guarantee the safety, quality, and efficacy of the products due to non-compliance with regulatory provisions.
Product details
The details of the counterfeit products are as follows:
Product Name | Avastin Vials 400 mg/16 ml |
Stated Manufacturer | F. Hoffmann- La Roche Ltd, Basel, Switzerland by Roche Diagnostics GmbH, Mannheim, Germany. |
Batch Number | K1830T71 H0375B01 |
Manufacturing Date | 04/2025 02/2025 |
Expiry Date | 05/2028 12/2027 |
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit product 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, 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
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
