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Oluwafemi Awodele
2 weeks ago
Overview
The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the recall of Amoxivue (Amoxicillin) 500mg, with NAFDAC NO: A4-100178 and Batch NO: 322584, manufactured by Sparsh Bio-Tech Pvt, Ltd.
A batch of Amoxivue capsules (Amoxicillin 500mg), manufactured in 10/ 2023 and expiring in 10/ 2026, was sampled from a facility in Sokoto and two facilities in 2 local government areas in Plateau State. The capsules were analyzed using High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectroscopy (FTIR).
The laboratory analysis report showed that the Active Pharmaceutical Ingredient (API) content was significantly low at 26.3%. Furthermore, the weight variation and infrared absorption spectrum of the sample residue did not meet the established specifications. This indicates that the product is substandard, which has led to its recall.
