The National Agency for Food and Drugs Administration and Control (NAFDAC) has alerted the public about the circulation of counterfeit Paludex tablets and suspensions across Nigeria, warning of serious health risks.
In a statement posted on its X handle on Wednesday, NAFDAC revealed that the counterfeit Artemether/Lumefantrine tablets (80mg/480mg), sold under the Paludex brand, were manufactured by Impact Pharmaceutical Ltd at No. 33A/33B Standard Industrial Layout, Emene, Enugu State.
These fake products are marketed by MD Life Sciences Ltd, also located in Emene Industrial Layout.
The counterfeit drugs also include the Paludex Artemether/Lumefantrine dry powder for oral suspension (180mg/1080mg), intended for pediatric use, which is produced by both Impact Pharmaceutical Ltd in Enugu and Ecomed Pharma Limited in Ogun State, and marketed by MD Life Sciences Ltd.
NAFDAC emphasized that laboratory tests carried out by a WHO-prequalified laboratory in Germany confirmed that the products contained zero per cent Active Pharmaceutical Ingredient (API). NAFDAC’s own analysis yielded the same result.
In its statement, NAFDAC noted: “The products do not exist on NAFDAC registered product database and all NAFDAC registration numbers stated on the products are false.”
The agency also explained the significance of the genuine Artemether/Lumefantrine combination tablets and suspension, which are used for treating acute malaria in both adults and children.
“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,” NAFDAC warned.
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“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,” it added.
To prevent further distribution of the counterfeit products, NAFDAC has directed all zonal directors and state coordinators to conduct surveillance and eliminate the fake products within their zones and states.
The agency also urged distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid the distribution, administration, and use of these counterfeit products.
NAFDAC advised: “All medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.”
Anyone in possession of the counterfeit Paludex products is encouraged to “immediately discontinue the sale or use and submit stock to the nearest NAFDAC office,” the agency said.
NAFDAC also advised the public, particularly those who have used the counterfeit products, to seek immediate medical attention from a qualified healthcare professional. Healthcare professionals and consumers were also urged to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office.
