The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted the public of a counterfeit batch of Herceptin 600mg/5ml injection in FCT, Abuja.
In Public Alert No: 011/2023 published on its Twitter handle, NAFDAC said 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, adding that the original product (BN: B1106B11, MFD: 03/2021 & EXD: 12/2022) was distributed in Georgia and was never shipped to Nigeria.
NAFDAC noted that the product did not come from MAH, and the batch tracing indicated that the genuine batch has already expired in December 2022.
Herceptin 600mg/5ml injection, according to NAFDAC, 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 contaminated Herceptin 600mg/5ml injection is B1106B11 manufactured in March 2022 with an expiring date of December 2024 manufactured by Roche Products Limited and marketed by RMPL PHARMA LLP – Mumbai.
NAFDAC further noted that 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.
NAFDAC, therefore, advises members of the public in possession of the above product to discontinue the sale or use and submit stock to the nearest NAFDAC office.
“If you have these counterfeit products, 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: [email protected]”
NAFDAC also advised healthcare professionals and patients 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 protected].
