PositiveNaija Public Alert 34: The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public about the sale of confirmed substandard and Falsified ARTEMETRIN DS and as CIPROFIT 500 in Nigeria.
The ARTEMETRIN DS (Artemether/Lumefantrine) tablet (80mg/480mg) is labelled manufactured by A.C. DRUGS Ltd, Plot C5/C6 Old Airport Road, Emene- Enugu State, Nigeria.
Also, the CIPROFIT 500 (Ciprofloxacin Tablet USP 500mg) is labelled and manufactured by Impact Pharmaceutical Ltd, No. 33A/33B Standard Industrial Layout Emene- Enugu State, Nigeria
Both products were initially subjected to thin-layer chromatography (TLC), which showed indications of irregularities on both products, thereby prompting further analysis at a WHO-prequalified laboratory. The results of the HPLC assay confirmed the following:
- ARTEMETRIN DS (Artemether/Lumefantrine) tablets (80mg/480mg) contain only 59.2% Artemether and 71.2% Lumefantrine, outside the expected 90-110% limits.
- CIPROFIT 500 (Ciprofloxacin Tablet USP 500mg) contained only 5.7% of Ciprofloxacin, outside the expected 90-110% limits.
It is important to note that the products were purchased from a “licensed vendor and wholesaler”. The products do not exist on the NAFDAC-registered product database, and all NAFDAC registration numbers stated on both products are false.
Genuine Artemether/Lumefantrine tablets combine Artemether and Lumefantrine to treat acute, uncomplicated malaria in both adults and children.
Ciprofloxacin Tablets 500 mg is indicated for the treatment of a wide variety of infections caused by susceptible bacteria, such as Respiratory Tract Infections, Urinary Tract Infections, Skin and Soft Tissue Infections, Surgical Infections, Bone and Joint Infections, Pelvic Infections, Sexually Transmitted Diseases, Gastrointestinal Infections, and Severe Systemic Infections. It may also be used for infections caused by multidrug-resistant bacteria.
Risk
Poor-quality medicines can lead to treatment failure, antimicrobial resistance, etc., if the active pharmaceutical ingredient (API) content is below the prescribed dosage.
Also, the marketing of substandard, falsified, or unregistered medicines poses a great risk to people’s health; by not complying with the regulatory provisions, the safety, quality, and efficacy of medicinal products are not guaranteed.
The details of the affected product are as follows.
| Product Name | ARTEMETRIN DS (Artemether 80mg + Lumefantrine 480mg) | CIPROFIT 500 (Ciprofloxacin Tablet USP 500mg) |
| Description | Tablets | Tablets |
| Stated manufacturer | A.C DRUGS Ltd, Plot C5/C6 Old Airport Road, Emene- Enugu State, Nigeria. | Impact Pharmaceutical Ltd, No. 33A/33B Standard Industrial Layout Emene- Enugu State, Nigeria. |
| Stated dose | (80mg/480mg) | (500mg) |
| Stated NAFDAC Reg. No | A4-3164 | 04-7405 |
| Batch No. | All batches | All batches |
| Packaging language | English/French | English / French |
| Identified in | Nigeria | Nigeria |
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard/falsified products within their zones and states.
NAFDAC implores distributors, suppliers, wholesalers, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, sale, administration, and use of the products. All medical products must be obtained from genuinely authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you have any of the products mentioned above, please stop selling or using them immediately and submit your stock to the nearest NAFDAC office. If you or someone you know has used any of these products and experienced adverse reactions or events, we strongly recommend seeking immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines 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 the medicinal product 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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