The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert recalling Amoxivue (Amoxicillin) 500mg capsules due to dangerously low levels of the active pharmaceutical ingredient (API).
The affected batch, with Batch Number 322584 and NAFDAC Registration Number A4-100178, was manufactured by Sparsh Bio-Tech Pvt. Ltd. in India in October 2023. The expiry date is October 2026.
Only 26% of Amoxicillin Found in Capsules
NAFDAC’s lab tests revealed that the capsules contained just 26.3% of the required amoxicillin content. Samples were collected from one facility in Sokoto and two others in Plateau State.
The analysis was done using High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectroscopy (FTIR). The product also failed tests for weight variation and infrared absorption spectrum.
“This confirms the batch is substandard and unsuitable for medical use,” NAFDAC said in its official alert.
Amoxivue is a common antibiotic used to treat infections like pneumonia, sinusitis, ear infections, UTIs, and skin infections. It belongs to the penicillin group and works by stopping bacterial growth.
When the API is too low, the drug becomes weak. It can’t fight infections properly and may cause treatment failure or resistance.
Public Health at Risk, NAFDAC Warns
NAFDAC warned that using the recalled batch could lead to “therapeutic failure, antibiotic resistance, increased risk of complications, and misleading clinical assessments.”
The agency directed all zonal directors and state coordinators to begin a nationwide mop-up of the product. Pharmacies, hospitals, and distributors must stop selling or using the affected batch immediately.
Consumers are advised to check their medicine packs. If you have Amoxivue 500mg with Batch No. 322584, stop using it and report it.
Suspected cases of substandard or fake drugs should be reported to the nearest NAFDAC office. You can also call 0800-162-3322 or email sf.alert@nafdac.gov.ng.
All medicines should be bought from licensed suppliers. Always check the packaging and expiry date before use.
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