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.
Amoxivue (amoxicillin 500 mg capsules) is an antibiotic used to treat various bacterial infections, including respiratory tract infections, ear infections, sinus infections, urinary tract infections (UTIs), and skin and soft tissue infections. It contains amoxicillin, a penicillin-type antibiotic that works by inhibiting the growth of bacteria.
Risk Statement
Administration of Amoxivue (Amoxicillin 500 mg) with low levels of amoxicillin may lead to therapeutic failure, antibiotic resistance, increased risk of complications, misleading clinical assessments, and poses a risk to public health.
Product details
The details of the affected batch are as follows:
Product Name Product Manufacturer: Manufactured Date
Expiry Date | Amoxivue (Amoxicillin) 500mg capsules Sparsh Bio-Tech Pvt, Ltd. Plot NO.1, Survey NO: 242/243/244 Lakhabavad Jamnagar -361006, Gujarat, India 10/2023 10/2026 |
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the Amoxivue (Amoxicillin) 500mg capsules within the zones and states.
Distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance in the supply chain to prevent the distribution, sale, and use of substandard products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices 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 medicinal products or devices 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
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
Product Images
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