The National Agency for Food and Drugs Administration and Control (NAFDAC) informs the healthcare providers and the public of a report of Confirmed Counterfeits of Tecentriq injection in Nigeria.
The Marketing Authorization Holder (MAH) Roche reported that an oncologist from a local hospital raised the suspicion for counterfeited material of Tecentriq Vials 1200 mg/20 ml, batch B0033B03.
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 was no sample available to Roche for investigation, only pictures displaying a folding box of Tecentriq 1200 mg/20 mL. No pictures of vial or leaflet were available.
On investigation, the following were discovered for each product.
Tecentriq Vials 1200 mg/20 mL, batch B0033B03
The genuine product of Tecentriq Vials 1200 mg/20 ml, batch B0033B03, was distributed by Roche to Türkiye in February 2022. The Kaiseraugst/Switzerland Quality Control organization site investigated the complaint sample pictures. The displayed complaint sample was compared to a batch corresponding retain sample in a Turkish makeup presentation.
Significant differences were observed regarding the displayed packaging material. The folding box (including the Tamper Evident label) does not correspond to genuine Roche Tecentriq packaging material. The English text appears to have been translated from Turkish (e.g. using a translation tool).
TECENTRIQ is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy.
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 | Tecentriq Vials 1200 mg/20 ml |
Stated Manufacturer | Roche |
Batch Number | B0033B03 |
Manufacturing Date | Not provided on the pack |
Expiry Date | 02/09/25 |
Product picture
Tecentriq
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, 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!!!
