NAFDAC Warns Against Fake Paludex Tablets in Circulation

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding the sale and distribution of counterfeit Paludex tablets and suspensions across Nigeria.

In a statement shared on its X handle, NAFDAC highlighted that the Paludex Artemether/Lumefantrine tablets (80mg/480mg) are manufactured by Impact Pharmaceutical Ltd, located at 33A/33B Standard Industrial Layout, Emene, Enugu State.

However, these counterfeit drugs are being marketed by MD Life Sciences Ltd, also based in Enugu. NAFDAC further revealed that the counterfeit Paludex Artemether/Lumefantrine dry powder for oral suspension (180mg/1080mg) for pediatric use is also circulating in the market. This formulation is produced by both Impact Pharmaceutical Ltd (Enugu) and Ecomed Pharma Limited (Ogun State), with marketing handled by MD Life Sciences Ltd.

Laboratory analysis from a WHO-prequalified lab in Germany confirmed that both products contained no active pharmaceutical ingredients (APIs). NAFDAC also conducted similar testing, which yielded the same result, showing zero content of APIs in the products. Additionally, the products are not listed in NAFDAC’s official product database, and all the NAFDAC registration numbers on the products are fraudulent.

The genuine Paludex Artemether/Lumefantrine tablets and suspensions, which combine the two medications, are used to treat acute, uncomplicated malaria in both adults and children. The circulation of counterfeit medicines presents significant health risks, as they do not meet the necessary safety, quality, or efficacy standards. Substandard pediatric formulations, in particular, could lead to treatment failure if the API content is insufficient.

In response to this issue, NAFDAC has instructed its zonal directors and state coordinators to conduct surveillance and remove the counterfeit products from the market. The agency has urged distributors, healthcare providers, and patients to remain cautious and ensure that all medications are sourced from authorized suppliers. It is also critical to inspect products for authenticity and condition before use.

Anyone possessing the counterfeit products is urged to stop selling or using them immediately and report their stock to the nearest NAFDAC office. Those who have used any of these fake medicines should seek medical attention promptly.

NAFDAC also encourages healthcare professionals and consumers to report any suspected substandard or falsified medicines to the nearest NAFDAC office for further investigation.