In accordance with its mandate to safeguard public health, NAFDAC hereby issues a formal notice of blacklisting of MedVue Pharmaceutical Ltd.

Following routine post-marketing surveillance, samples of the above batch of Amoxivue (Amoxicillin) 500mg marketed by MedVue Pharmaceutical Ltd were collected from facilities in Sokoto and Plateau State. Laboratory analysis using High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectroscopy (FTIR) revealed:

• Active Pharmaceutical Ingredient (API) content: Critically low at 26.3%
• Weight variation and infrared absorption spectrum: Failed to meet established specifications

These findings confirm that the product is substandard and poses serious risks to public health, including:

• Therapeutic failure
• Development of antimicrobial resistance
• Increased risk of complications
• Misleading clinical outcomes

Further investigations revealed that the labelled manufacturer, Sparsh Bio-Tech Pvt, Ltd., has declared no relationship with the Marketing Authorization Holder (MAH), MedVue Pharmaceutical Ltd. This implies that the documents used to register the product Amoxivue (Amoxicillin) 500mg Capsules are forged and not authentic. In view of this, the company lacks the moral standing to manufacture quality products for public use; thus, the company is blacklisted, and all products registered and marketed by the company are hereby deregistered.

NAFDAC’s blacklisting mechanism serves to shield public health by:

1. Prohibiting the sale, distribution, or use of all products associated with the erring firm.
2. Alerting healthcare providers and consumers to potential safety hazards.

For MedVue Pharmaceutical Ltd, blacklisting entails:

• Immediate cessation and dealing (manufacturing, importation, exportation, distribution, and sales activities) in all forms of health products.
• Potential prosecution for offenses under the NAFDAC laws and regulations.

All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard/falsified products within their zones and states.

NAFDAC implores distributors, suppliers, wholesalers, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, sale, administration, and use of the products. All medical products must be obtained from genuinely authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. 

If you have the products mentioned above or any product marketed or distributed by MedVue Pharmaceutical Ltd, please stop selling or using them immediately and submit your stock to the nearest NAFDAC office. If you or someone you know has used any of these products and experienced adverse reactions or events, we strongly recommend seeking 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: 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 the medicinal product 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  

Thank you.

Prof. Mojisola Christianah Adeyeye FAS
Director General