National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning about the illegal circulation and marketing of substandard and falsified Knowit Insulin Syringe 40 IU 29g X 1/2 in Nigeria.
In a statement on Monday, March 3, NAFDAC said the Association of Community Pharmacists of Nigeria (ACPN) had raised concerns over the continued use of 40 IU/ML insulin syringes despite the availability of 100 IU/ML insulin syringes.
According to the agency, the 40 IU/ml insulin syringe was previously approved for administering Lente animal insulins, which were available in both 40 IU/ml and 100 IU/ml strengths. However, with the discontinuation of animal insulins and the introduction of human insulins standardized at 100 IU/ml, the use of 40 IU/ml syringes has become obsolete and is no longer registered by NAFDAC.
The agency warned that using a 40 IU/ml syringe for administering 100 IU/ml insulin could lead to dosing errors, posing severe health risks for diabetic patients.
NAFDAC identified the falsified product with registration number 03-2933, a manufacturing date of August 2020, and an expiry date of August 2025. It listed Chivic Limited as the distributor but noted that the registration number on the product was fraudulent, as the license had expired in 2019.
The agency emphasized that insulin dosing errors could be life-threatening and lead to serious complications for diabetic patients. It also condemned the illegal marketing of medical products, stating that substandard and falsified drugs pose significant public health risks.
NAFDAC has directed all zonal directors and state coordinators to conduct surveillance and remove the falsified products from circulation. The agency urged importers, distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance within the supply chain to prevent the importation, distribution, sale, and use of substandard and falsified medical products.
NAFDAC advised that all medical products should be sourced only from authorized and licensed suppliers, with thorough checks on authenticity and physical condition to ensure safety.
