The National Agency for Food and Drug Administration and Control (NAFDAC) has raised an alarm about counterfeit Paludex tablets and suspensions circulating in Nigeria, warning of serious health risks due to their zero Active Pharmaceutical Ingredient (API) content.
Key Details:
1. Fake Products: Paludex Artemether/Lumefantrine tablets (80mg/480mg) and dry powder for oral suspension (180mg/1080mg)
2. False Manufacturers: Impact Pharmaceutical Ltd, Ecomed Pharma Limited
3. Distributor: MD Life Sciences Ltd
4. Location: Enugu and Ogun States
5. Risk: Treatment failure, health risks due to zero API content
NAFDAC urges caution and vigilance in the supply chain, emphasizing the importance of obtaining medical products from authorized/licensed suppliers and carefully checking their authenticity and physical condition.
Background:
Laboratory tests conducted by a WHO-prequalified laboratory in Germany revealed that both products contained zero percent of the Active Pharmaceutical Ingredients (API). Additional tests conducted by NAFDAC confirmed the absence of any API in the products.
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NAFDAC’s Warning:
“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. Poor-quality pediatric formulations or medicines in general have the potential of causing treatment failure when the API content is below the prescribed dose.”
Action Taken:
NAFDAC has directed its zonal directors and state coordinators to carry out surveillance and mop up the fake products within their zones and states. The agency implores distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the products.
Safety Precautions:
1. Obtain medical products from authorized/licensed suppliers.
2. Carefully check the products’ authenticity and physical condition.
3. Verify the NAFDAC registration numbers displayed on the packaging.
4. Report any suspicious products to NAFDAC.
Stay updated on Dataxpat News for further reports on this developing story.
Source: Nation