The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the illegal circulation and marketing of a substandard and falsified Knowit Insulin Syringe 40 IU 29g X 1/2 in Nigeria.
The Association of Community Pharmacists of Nigeria (ACPN) raised concern regarding the ongoing use of 40 IU/ML insulin syringes despite the availability of 100 IU/ML insulin syringes.
The 40iu/ml Insulin syringe was previously approved alongside the 100iu/ml for administering Lente animal insulins because of its presentation in both strengths.
However, with the discontinuation of animal insulins and the advent of human insulins whose strengths are streamlined to 100 iu/ml, the 40iu/ml insulin syringe is no longer applicable and not registered anymore by NAFDAC as it could cause dosing errors with serious adverse consequences on diabetic patients using them.
Risk Statement
Using a 40 IU/ML syringe for administering 100 IU/ML insulin exposes patients to a high risk of dosing errors, as the computation required to adjust for this mismatch cannot be reliably performed by most patients. Insulin dosing errors are life-threatening and could result in severe complications for diabetic patients.
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.
Product details
The details of the product are as follows.
Product Brand Name: Knowit Insulin Syringe
Generic Name: Insulin Syringe 40IU 29G x 1/2
Batch Number: N/A
NAFDAC Reg No: 03-2933
Manufacturing Date: 2020.08
Expiry Date: 2025.08
Name and Address of Manufacturer: Unknown
Distributor: Chivic Limited
Please note that the above NRN (NAFDAC Registration Number) is falsified as the product license expired in 2019.
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.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
