Nigerian Public Alert 71: The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying healthcare providers and the public of the circulation of counterfeit or falsified Augmentin 625mg Tablets (2 x 7 tablets pack) with Batch No. AC3N in Nigeria.
NAFDAC has received information from the Marketing Authorization Holder for GlaxoSmithKline products in Nigeria regarding suspected counterfeit Augmentin 625mg Tablets.
This alert follows a series of complaints received by the genuine manufacturer, GlaxoSmithKline (GSK), regarding suspected counterfeit Augmentin 625mg Tablets bearing the Batch No. AC3N, circulating in Nigeria.
GSK evaluated and confirmed that the suspected product was counterfeit after reviewing documentary evidence, photographs, and a video from social media. Although the product shared the same batch number as authentic stock previously supplied to Nigeria, it exhibited inconsistent manufacturing and expiry dates, indicating that it had been falsified.
Findings from Manufacturer’s Investigation
- Batch AC3N was manufactured at Worthing, United Kingdom, on 23 August 2023.
- The batch was packed between 19 and 20 September 2023.
- No batch with the number AC3N was produced in September 2025.
- The manufacturing and expiry dates shown on the suspect sample (Manufacturing: September 2025 / Expiry: September 2028) are inconsistent with GSK production records and cannot be attributed to a GSK-produced batch.
- Packaging-level discrepancies, including textual errors and poor fin seal quality, were identified.
- Based on the evidence reviewed, the product was assessed as counterfeit.
Augmentin (amoxicillin/clavulanic acid) is an antibiotic used for the treatment of bacterial infections. Any falsified version may contain incorrect amounts of active ingredients, no active ingredient, or harmful substances.
Risk Statement
Counterfeit medicines pose serious risks to public health and safety. The use of counterfeit Augmentin 625mg Tablets may result in treatment failure, worsening of bacterial infections, development of antimicrobial resistance, adverse drug reactions due to unknown or harmful ingredients, and delay in receiving appropriate medical care.
Product Details
The details of the products are as follows:
Product Name: Augmentin 625mg Tablets
Pack Size: 2 x 7 Tablets
Batch Number: AC3N
Manufacturer of Genuine Product: GlaxoSmithKline (GSK), Worthing Site, United Kingdom
NAFDAC remains committed to safeguarding public health by ensuring that only safe, efficacious, and quality medicines are available in Nigeria.
All zonal directors and state coordinators have been directed to conduct surveillance and mop-up activities to identify and remove any counterfeit Augmentin 625mg Tablets from circulation in Nigeria.
Importers, distributors, retailers, healthcare professionals, and consumers are advised to exercise caution and vigilance throughout the supply chain to avoid the purchase or use of the counterfeit Augmentin 625mg Tablets in circulation. All medical products must be obtained from authorized or licensed suppliers. The authenticity and physical condition of these products should be carefully checked before use.
Consumers who have purchased or are currently using Augmentin 625mg Tablets suspected to be counterfeit should stop using the product immediately and consult a qualified healthcare professional.
Healthcare professionals are advised to review the stocks in hospitals, clinics, and pharmacy stores, immediately quarantine the stock, and discontinue sale or distribution of any suspected counterfeit. Report any suspected falsified or compromised products (medicines or medical devices) to the nearest NAFDAC office, call 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
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