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  5. Public Alert No. 08/2024 – Alert on Falsified Coco Samba Herbal Mixture Containing Sildenafil Discovered…

Public Alert No. 08/2024 – Alert on Falsified Coco Samba Herbal Mixture Containing Sildenafil Discovered in Germany

The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of discovery of falsified Coco Samba Herbal Mixture 100ml in circulation.

The product was seized by German customs and analysed by the German Official Medicines Control Laboratory (OMCL). The report of analysis showed that the product contained undeclared amounts of sildenafil (150mg) which is above the maximum daily dose for sildenafil.

On further investigation, it was discovered that the NAFDAC Registration Number on the product “A4-9149” is falsified and different from that obtained from the NAFDAC database “A8-4418L” for the geniun product. Laboratory analysis conducted by the Agency also confirmed the presence of undeclared sildenafil content.

Sildenafil is a medicine prescribed for the treatment of erectile dysfunction and pulmonary arterial hypertension (PAH).

Risk Statement

Sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The adult male population who are most likely to use this product with nitrates (in prescription drugs for cardiac conditions), are most at risk.

Product Details

The details of the falsified product are as follows:

Product NameCoco Samba Herbal Mixture
Pack Size100ml
Stated Manufacturer and AddressBullion Go-neat global ltd.

 

1, Amras Crescent, Torotoro quarters, Km 36, Lagos Ibadan Expressway, Ibafo, Ogun State, Nigeria. 

Stated NAFDAC Reg.No. (NRN)A8-9149
Batch number008
Expiry date08/2024
Date of manufacture08/2023

Though the falsified product was intercepted in Germany, it is likely that it may have been distributed within the country through informal channels. Consequently, it is important to detect and remove it from circulation to prevent harm to consumers.

NAFDAC implores importers, distributors, retailers and healthcare providers to always exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and administration or use of falsified or substandard medicinal products or contaminated food products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. 

Members of the public in possession of the above product are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.

If you have this falsified product, please DO NOT use it. If you, or someone you know, have used this product, 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 sale 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 this medicinal products 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

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

Signed Management

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