The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public about the recall of two products: Astamocil (Amoxicillin Suspension 125mg/5ml), Batch 826024, and Astamentin (Amoxicillin/Clavulanic Acid Suspension 228.5 mg), Batches 0503024 and 0501724, manufactured by Sam-Ace Ltd in Nigeria.
The products were discovered by the Agency’s Post Marketing Surveillance Directorate Officers following a recent Risk-Based Post-Marketing Surveillance conducted in the Coordinated Wholesale Center (CWC) in Kano.
Laboratory investigation carried out on the products showed that both suspensions failed laboratory analysis due to low API content.
The company has been directed to recall the failed batches of the products from circulation.
AMOXICILLIN is a penicillin-class antibacterial indicated for the treatment of infections due to susceptible strains of designated microorganisms. Amoxicillin alone is indicated to treat susceptible bacterial infections of the ear, nose, throat, genitourinary tract, skin, skin structure, and lower respiratory tract.
Amoxicillin and Clavulanic Acid is a combination prescription antibiotic. Amoxicillin is a penicillin antibiotic that fights bacteria in the body, as mentioned earlier. Clavulanic acid is a beta-lactamase inhibitor that helps prevent certain bacteria from becoming resistant to amoxicillin.
Amoxicillin and Clavulanic Acid are used to treat many different infections caused by bacteria, such as sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and skin infections.
Risk Statement
The risk of low Active Pharmaceutical Ingredient (API) in medicines includes ineffective treatment, development of antimicrobial resistance, and serious safety concerns.
Product Details
The details of the substandard products and batches are as follows;
Product Name | Manufacturer | Batch No | Mfg. Date | Exp. Date | NRN NO |
Astamocil (Amoxicillin Suspensions 125mg/5ml)
| Sam-Ace Ltd, Plot 9/10, Block 7C, Akoda Industrial Estate, KM 14, Gbongan/Ibadan Rd. Akoda-Ede, Osun State. | 826024
| 09/2024
| 08/2027
| A4-8681
|
Astamentin (Amoxicillin/Clavulanic Acid 228.5mg/5ml) | Same as above | 0501724 | 07/2024 | 06/2026 | A11-0341
|
Astamentin (Amoxicillin/Clavulanic Acid 228.5mg/5ml) | Same as above | 0503024 | 10/2024
| 09/2026
| A11-0341
|
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard products within the zones and states.
Distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid 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).
NAFDAC………. Customer-focused, Agency-minded!!!
