Nigerian Public Alert 64: The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare professionals and the public of a confirmed counterfeit batch of Herceptin 600 mg circulating in Nigeria. This alert follows official communications from Roche Nigeria confirming a counterfeit case of Herceptin 600 mg with batch number A8519B34 reported in Lagos state, Nigeria.
According to the Marketing Authorization Holder (MAH), the report of a counterfeit batch of Herceptin 600 mg was received as a complaint from a customer. The counterfeited batch of the product was said to have been offered to a customer by a pharmacist in Lagos at a significantly lower price of NGN 50,000 compared to the standard rate.
On investigation, the MAH (Roche Nigeria) compared the pictures of the counterfeit Herceptin 600mg provided by the complainant to the genuine packaging material of Herceptin 600 mg. The comparison revealed significant differences from genuine packaging material, which includes:
- Wrong artwork,
- Wrong expiry date,
- Incorrect 2D matrix code.
- The lot tracing is not possible because the batch number A8519B34 is not a genuine Roche batch number for Herceptin.
Chemical analysis was not possible because the physical sample was not available for return.
Herceptin (trastuzumab) is a prescription drug used to treat certain types of breast cancer and stomach cancer. It works by inhibiting cancer cell growth and is administered via intravenous infusion or injection, often alongside chemotherapy
Risk Statement
Counterfeit oncology medicines may contain incorrect or no active ingredients, harmful contaminants, or incorrect dosage strength. This may result in treatment failure, disease progression, serious adverse events, or death
Product details
The details of the counterfeit products are as follows:
| Product Name | Stated Manufacturer | Batch Number | Manufacturing Date | Expiry Date |
| Herceptin 600 mg | F.Hoffmann-La Roche Ltd, Kaiseraugust, Switzerland | A8519B34 | 01/2024 | 11/2026 |
The genuine Herceptin 600 mg is manufactured by F. Hoffmann-La Roche Ltd in Basel, at the Kaiseraugust site in Switzerland.
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
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