The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an urgent warning regarding the illegal circulation and marketing of substandard and falsified Knowit Insulin Syringe 40 IU 29g X 1/2 in Nigeria.
In a statement released on Monday, March 3, NAFDAC highlighted concerns raised by the Association of Community Pharmacists of Nigeria (ACPN) over the continued use of 40 IU/ML insulin syringes despite the availability of safer, 100 IU/ML syringes.
NAFDAC explained that the 40 IU/ml syringe was previously approved for administering Lente animal insulins, which are no longer in use. With the introduction of human insulins standardized at 100 IU/ml, the 40 IU/ml syringe is now obsolete and no longer registered by NAFDAC. Using the 40 IU/ml syringe with 100 IU/ml insulin could result in dangerous dosing errors, posing severe health risks to diabetic patients.
The agency identified the falsified product, which had a fraudulent registration number (03-2933), a manufacturing date of August 2020, and an expiry date of August 2025. The product was reportedly distributed by Chivic Limited, although the registration number expired in 2019.
NAFDAC stressed that insulin dosing errors could be life-threatening and urged strict vigilance in preventing the circulation and use of substandard or falsified medical products. The agency has instructed zonal directors and state coordinators to remove these products from circulation and called on healthcare professionals, importers, distributors, and retailers to source medical products only from authorized suppliers.