The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to Nigerians regarding the unlawful distribution and promotion of a substandard and counterfeit Knowit Insulin Syringe 40 IU 29g X 1/2 within the nation.
In an official statement, NAFDAC indicated that the Association of Community Pharmacists of Nigeria (ACPN) expressed concerns about the use of 40 IU/ML insulin syringes, despite the availability of 100 IU/ML syringes.
“The 40 IU/ml insulin syringe was previously authorized alongside the 100 IU/ml for the administration of Lente animal insulins due to its availability in both strengths,” the statement noted.
“However, with the cessation of animal insulins and the introduction of human insulins, which are standardized to 100 IU/ml, the 40 IU/ml insulin syringe is no longer relevant and has not been registered by NAFDAC, as its use could lead to dosing errors with potentially serious repercussions for diabetic patients.”
The agency reported that the NAFDAC number on the counterfeit product is 03-2933, with a manufacturing date of August 2020 and an expiry date of August 2025, and the distributor listed is Chivic Limited.
NAFDAC emphasized that the registration number on the product is fraudulent, as the license expired in 2019.
The agency warned that utilizing a 40 IU/ML syringe for administering 100 IU/ML insulin significantly increases the risk of dosing errors for patients.
“Errors in insulin dosing can be life-threatening and may lead to severe complications for individuals with diabetes,” the agency stated.
“Moreover, the illegal marketing of medical products, including substandard and counterfeit items, presents a considerable threat to public health.
“Non-compliance with regulatory standards undermines the safety, quality, and effectiveness of these products.
“All zonal directors and state coordinators of NAFDAC have been instructed to conduct surveillance and eliminate the substandard and counterfeit products within their respective zones and states.”