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The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians about the illegal circulation and marketing of a substandard and falsified Knowit Insulin Syringe 40 IU 29g X 1/2 in the country.
In a statement on Monday, NAFDAC said the Association of Community Pharmacists of Nigeria (ACPN) raised concern that 40 IU/ML insulin syringes are being used while 100 IU/ML insulin syringes are available.
“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insulins and the advent of human insulins whose strengths are streamlined to 100 IU/ml, the 40 IU/ml insulin syringe is no longer applicable and not registered anymore by NAFDAC, as it could cause dosing errors with serious adverse consequences on diabetic patients using them.”
The agency said the NAFDAC number on the falsified product is 03-2933, the manufacturing date is 2020-08, the expiry date is 2025-08, and the distributor is Chivic Limited.
The agency said the registration number on the product is falsified, noting that the license expired in 2019.
NAFDAC said the use of a 40 IU/ML syringe for administering 100 IU/ML insulin exposes patients to a high risk of dosing errors.
“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.”
