The National Agency for Food and Drugs Administration and Control (NAFDAC) informs the healthcare providers and the public of a report of Confirmed Counterfeit of Avastin in Nigeria.
The Marketing Authorization Holder (MAH) Roche reported that an oncologist from a local hospital raised the suspicion for counterfeited material of Avastin Vials 400 mg/16 ml, batch H0223B08.
The folding box of the unit did not have a NAFDAC number, which is required for sale in Nigeria. The unit was purchased in Lagos at a lower price compared to prices on NCAP (Nigeria Cancer Access Partnership).
There is no sample available to Roche for investigation, only pictures displaying parts of an Avastin 400 mg/16 mL folding box. No pictures of vial or leaflet are available.
On investigation, the following were discovered for each product.
Avastin Vials 400 mg/16 mL, batch H0223B08
The genuine product of Avastin Vials 400 mg/16 ml, batch H0223B08, was distributed by Roche to Vietnam (VN) in July 2020 (expired after 10.02.2022).
The Kaiseraugst/Switzerland Quality Control organization investigated the complaint sample pictures. The displayed complaint sample was compared to retain samples in VN make-up presentation based on the batch number, and to an EFA make-up presentation as the GTIN (Global Trade Item Number) of the folding box belongs to an Avastin 400 mg/16 mL with EFA make-up.
The folding box (including the Tamper Evident label) does not correspond to genuine Roche Avastin packaging material.
The Chemical analysis was not possible for both cases, as the physical complaint samples were not available for return. Nevertheless, an examination of the provided images confirmed clear evidence of counterfeit packaging material in both cases.
AVASTIN is indicated for the treatment of recurrent glioblastoma in adults. It is a tumor-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 | Roche |
Batch Number | H0223B08 |
Manufacturing Date | 05/2023 |
Expiry Date | 07/2026 |
Product picture
Avastin
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
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
