Recalls & Alerts Published by NAFDAC

The National Agency for Food and Drug Administration and Control hereby inform the general public of FDA’s warning against the use of “Best Bentonite Clay,” a product of Best Bentonite, located in Guthrie, Oklahoma USA. Best Bentonite is used by consumers for healing purposes by mixing the product with water and ingesting it or for skin care. It is sold as a fine powder on Amazon.com or Best Bentonite website.

The product was found to contain elevated lead levels and may pose a lead poisoning risk. Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system. In children, chronic exposure to lead, even at low levels, is associated with cognitive impairment, reduced IQ, behavioral difficulties, and other problems.

NAFDAC implores the members of the public, importers and consumers not to purchase or use the product.

NAFDAC implores all outlets with stock of this product to immediately remove them from circulation. 

Healthcare professionals and consumers should report adverse events from use of the product to NAFDAC PRASCOR (20543-Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC…..Safeguarding the health of the Nation!!!

The agency has recently been notified on the suspension of Farma Mediterrania, a drug manufacturing company based in Barcelona, Spain by European Medicine Agency Regulators. The FDA queries the quality assurance system of the company and finds the equipment and procedure used in their manufacturing stream as nonqualified.

The FDA also recalled all the pharmaceuticals produced by the company enlisted below:

Drug Specifications

S/N Active Ingredient Pharmaceutical Form Strength Presentation Classification
1 Alprostadi Solution for Injection 20µg/ml, 500µg/ml Liquid ampoules Prescription
2 Azithromycin Powder for Injection 500mg Lyophilised vials Prescription
3 Clarithromycin Powder for Injection 500mg Lyophilised vials Prescription
4 Colistimethate Powder for Injection 1 & 2mg/2ml Lyophilised vials Prescription
5 Dobutamine Solution for Injection 250mg/20ml Liquid 20ml ampoules Prescription
6 Esomeprazole Powder for Injection 40mg Lyophilised vials Prescription
7 Flumazenile Solution for Injection 0.1mg/ml 5 & 10ml Liquid Ampoules Prescription
8 Hydrocortisone Powder for Injection 100mg/ml, 500mg/5ml Lyophilised vials Prescription
9 Noradrenaline bitartrate Solution for Injection 1mg/ml 4, 5 & 10ml Liquid ampoules Prescription
10 Noradrenaline bitartrate Solution for Injection 2mg/ml 2, 4 & 20ml Liquid ampoules Prescription
11 Omeprazole Powder for Injection 40mg Lyophilised vials Prescription
12 Ondansetron Solution for Injection 2mg/ml 2 & 4ml Ampoules Prescription
13 Pantoprazole Powder for Injection 40mg Lyophilised vials Prescription
14 Phenytoin Solution for Injection 250mg/5ml Ampoules & Vials Prescription
15 Rivastigmine Oral solution 2mg/ml   Prescription
16 Ropivacaine Solution for Injection 20, 75 & 100mg Ampoules & bags Prescription
17 Teicoplanine Powder for Injection 200, 400mg Lyophilised vials Prescription
18 Vancomycin Powder for Injection 500mg, 1g Lyophilised vials Prescription
19 Vecuronium bromide Powder for Injection 10mg/3ml Lyophilised vials Prescription
20 Valproic acid Powder for Injection 400mg/4ml Lyophilised vials Prescription
21 Zolendronic Solution for Injection 4mg/5ml Liquid vials Prescription

Healthcare providers and consumers should report adverse events to NAFDAC PRASCOR (20543 – Toll free from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC…Safeguarding the health of the Nation!!!

Wednesday, 25 May 2016 10:52

Public Alert On Ninja-X Enhancement Drug

The Agency has been notified against the use of Ninja-X, a product promoted and sold for sexual enhancement online and in retail stores. Ninja-X has been confirmed to contain Sildenafil and Thiosildenafil. Thiosildenafil is structurally similar to sildenafil, a drug used to treat erectile dysfunction.

These contents may interact with drug products like antilipidemics, antidiabetics and antihypertensive which often contain nitrates, which may lower Packed Cell Volume (PCV) to very dangerous levels.

NAFDAC implores importers and the general public to desist from the importation and purchase of this product.

Adverse events associated with the use of the product should be reported to the nearest NAFDAC office, NAFDAC PRASCOR (20543- TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

 

NAFDAC…Safeguarding the health of the Nation!!!

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