Nigerian Public Alert 49: The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting healthcare providers, patients, and the public about a report concerning the circulation of a revalidated and unregistered Natrilix SR (Indapamide 1.5mg) found on sale in Nigeria.
The investigation report reveals that one of the batches found is revalidated, while another batch is a case of parallel importation. These issues raise significant concerns regarding the quality, safety, and efficacy of the products.
Natrilix 1.5 mg Tablet SR is a diuretic (also known as a water pill) used either alone or in combination with other medications to treat high blood pressure.
The integrity of the product’s potency and stability is highly dependent on compliance with regulatory requirements. Any alteration or extension of the shelf life without regulatory approval poses significant risks to public health.
Potential Risks:
Use of revalidated (altered-shelf life) medicines may lead to:
- Reduced therapeutic effect due to loss of potency
- Increased risk of treatment failure
- Development of antimicrobial resistance
- Adverse or unpredictable reactions
- Drug instability due to compromised storage or handling conditions
Product Details
The details of the revalidated vis-à-vis the parallel imported product are as follows;
| Status | Original | Revalidated | Parallel/Unregistered |
| Product Name | Natrilix SR (Indapamide 1.5mg) | Natrilix SR (Indapamide 1.5mg) | Natrilix SR (Indapamide 1.5mg) |
| Stated Manufacturer | SERVIER EGYPT INDUSTRIES LIMITED | SERVIER Egypt Industries Limited | SERVIER Egypt Industries Limited |
| Declared Ingredient | Indapamide | Indapamide | Indapamide |
| Batch | 32417 | 32417 | 34934 |
| Manufactured Date | 03/2023 | 03/ 2023 | 01/2025 |
| Expiring Date | 03/2025 | 03/ 2026 | 01/2027 |
| Stated NAFDAC Reg. No | 04-8509 | 04-8509 | No NRN |
NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines circulating in Nigeria.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the revalidated and unregistered products if found 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 the SF product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals are advised to review stocks within hospitals, clinics, and pharmacy stores, report any suspected falsified or compromised products (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
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