Nigerians have received a warning from the National Agency for Food and Drug Administration and Control (NAFDAC) on the illicit sale and distribution of a counterfeit and inferior Knowit Insulin Syringe 40 IU 29g X 1/2 in their nation.
The Association of Community Pharmacists of Nigeria (ACPN) expressed concern over the usage of 40 IU/ML insulin syringes when there are 100 IU/ML insulin syringes accessible, according to a statement released by NAFDAC on Monday.
“The 40 IU/ml insulin syringe was previously approved alongside the 100 IU/ml for administering Lente animal insulins because of its presentation in both strengths,” the statement reads.
“However, with the discontinuation of animal insulins and the advent of human insulins whose strengths are streamlined to 100 IU/ml, the 40 IU/ml insulin syringe is no longer applicable and not registered anymore by NAFDAC, as it could cause dosing errors with serious adverse consequences on diabetic patients using them.
According to the agency, the counterfeit product’s NAFDAC number is 03-2933, its production date is 2020-08, its expiration date is 2025-08, and its distributor is Chivic Limited.
The agency pointed out that the license expired in 2019 and said that the product’s registration number was fake.
As reported by NAFDAC, patients run a significant risk of dosage mistakes when using a 40 IU/ML syringe to give 100 IU/ML of insulin.
“Insulin dosing errors are life-threatening and could result in severe complications for diabetic patients,” the agency said.
“Additionally, the illegal marketing of medical products, or substandard and falsified medical products, poses a significant risk to public health.
“By failing to comply with regulatory provisions, the safety, quality, and efficacy of these products cannot be guaranteed.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard and falsified products within the zones and states.
“Importers, distributors, retailers, healthcare professionals, and caregivers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of substandard and falsified products.
“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.”
