Public Alert No: 011/2023 – Alert on Confirmed Counterfeit Herceptin 600mg/5ml Injection
April 2, 2023,
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that one batch of HERCEPTIN 600mg/5ml confirmed to be counterfeit has been identified in FCT, Abuja.
The Marketing Authorization Holder (MAH) Roche Products Limited has confirmed that HERCEPTIN 600mg/5ml with the product details (BN: B1106B11, MFD: 03/2022 & EXD: 12/2024) is falsified.
The original product (BN: B1106B11, MFD: 03/2021 & EXD: 12/2022) was distributed in Georgia and was never shipped to Nigeria.
According to the MAH, the product did not come from them and the batch tracing indicated that the genuine batch has already expired in December 2022.
HERCEPTIN 600mg/5ml injection is used to treat breast cancer whose tumour has tested positive to HER2. HERCEPTIN may be used alone or with other medicines that treat breast cancer, such as an aromatase inhibitor (hormone receptor positive breast cancer) or a taxane (e.g. paclitaxel or docetaxel).
The details of the contaminated product are as follows:
|Product Name||HERCEPTIN 600mg/5ml injection|
|Stated Manufacturer||Roche Products Limited|
|Stated to be marketed by||RMPL PHARMA LLP – Mumbai|
|Date of manufacture||03/2022|
Though this suspected counterfeit product was identified in the FCT, it is likely that it may have been distributed to other parts of the country through informal markets. Consequently, It is important to detect and remove it from circulation to prevent harm to patients.
NAFDAC implores importers, distributors, retailers and healthcare providers to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and administration or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Members of the public in possession of the above product are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.
If you have these counterfeit product, please DO NOT use it. If you, or someone you know, have used this product, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on
0800-162-3322 or via email: firstname.lastname@example.org
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products 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 email@example.com