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 Perjeta in Nigeria.
The Marketing Authorization Holder (MAH) Roche received a complaint from a pharmacist reporting two units of suspected counterfeit Roche products, Perjeta 420 mg/14mL.
For the technical investigation, Roche only received pictures displaying parts of a Perjeta 420 mg/14 mL folding box, batch K0593B12. No pictures of vials and leaflets were available.
On investigation, the following were discovered for each product.
Perjeta 420 mg/14 ml, batch K0593B12
The Kaiseraugst/Switzerland Quality Control organization investigated the complaint sample pictures. As the batch number is not a genuine Roche batch number, a comparison against a batch corresponding retain sample was not possible. Since the sample may mimic the Roche common make-up EFA, a corresponding retain sample was used for comparison.
Significant differences were found regarding the packaging materials. The folding box (including the Tamper Evident label) does not correspond to Roche Perjeta’s genuine packaging material. For an adequate investigation, a physical sample is needed.
Batch Trace: The lot tracing was impossible because the lot number imprinted is not a genuine Roche batch number for Perjeta.
Chemical Analysis: Chemical analysis was not possible, as the physical complaint sample was not available for return. Nevertheless, the investigation of the provided pictures revealed clear evidence of counterfeit packaging material.
Perjeta 420mg Injection is used to treat breast cancer when other medicines have failed to show significant improvement. It helps to stop cancer growth and further spread and relieves the symptoms of breast cancer such as breast lumps, bloody discharge from the nipple, or changes in the shape or texture of the breast.
Risk Statement
The illegal promotion or sale of counterfeit medicines puts people’s health at risk as it does not ensure the safety, quality, and effectiveness of the products.
Product details
The details of the counterfeit products are as follows:
Product Name | Perjeta 420 mg/14 mL |
Stated Manufacturer | Roche |
Batch Number | K0593B12 |
Manufacturing Date | Not provided on the pack |
Expiry Date | 05/2025 |
Product picture
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 product. 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, or 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!!!
