Public Alert No. 049/2024 -Sales and Distribution of Confirmed Counterfeit Paludex (Artemether/Lumefantrine ) Tablets (80mg/480mg) and Suspension (20mg/120mg)

The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public about the sales and distribution of confirmed counterfeit Paludex tablets and suspensions in Nigeria.

The Paludex (Artemether/Lumefantrine) tablets (80mg/480mg) are labeled manufactured by Impact Pharmaceutical Ltd, No. 33A/33B Standard Industrial Layout Emene- Enugu State, Nigeria and marketed by MD Life Sciences Ltd Emene Industrial Layout Enugu State, Nigeria.

The results of laboratory analysis on both products by a WHO-prequalified laboratory in Germany indicated zero percent (0%) API (Active Pharmaceutical Ingredient) in the products.  NAFDAC sampled the same products, and the reports of analysis confirmed zero percent (0%) of API contents.

Also, found in circulation is Paludex (Artemether/Lumefantrine) dry powder for oral suspension (180mg/1080mg) for paediatric use labeled manufactured by 1. Impact Pharmaceutical Ltd, No. 33A/33B Standard Industrial Layout Emene- Enugu State, Nigeria and 2.Ecomed Pharma Ltd, Sango-Ota, Ogun State. All are marketed by MD Life Sciences Ltd Emene Industrial Layout Enugu State, Nigeria.

It is important to note that the products do not exist on the NAFDAC registered product database and all NAFDAC registration numbers stated on the products are false.

Genuine Artemether/Lumefantrine tablets or suspension is a combination of the two medications Artemether and Lumefantrine used to treat acute, uncomplicated malaria in adults and children.

Risk

The illegal marketing of medicines or counterfeit medicines poses a great risk to the health of people; by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.

Also, poor-quality pediatric formulations or medicines in general have the potential of causing treatment failure when the API content is below the prescribed dose.

Product Details

The details of the affected product are as follows.

Product Photo

Please, see pictures of the Counterfeit products below.

Fig 1 & 2: Paludex Tablet

Fig 3 & 4: Paludex Suspension

Fig 5 & 6: Paludex Suspension

All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the falsified products within their zones and states.

NAFDAC implores distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. 

Anyone in possession of any of the above-mentioned products is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office. If you have used any of these products, or someone you know, has used any of it, or suffered any adverse reaction/event after use, you are advised to seek 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  

Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).

NAFDAC………. Customer-focused, Agency-minded!!!