The National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm over the illegal circulation and marketing of a substandard and falsified medical product, the Knowit Insulin Syringe 40 IU 29G x 1/2, in Nigeria.
The agency issued the warning in a statement on Monday, highlighting concerns from the Association of Community Pharmacists of Nigeria about the continued use of outdated 40 IU/ML insulin syringes despite the availability of the standardised 100 IU/ML syringes.
NAFDAC further warned that this syringe is no longer registered and its continued use poses a serious risk of dosing errors, which could lead to life-threatening complications for diabetic patients.
The statement reads: "The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public about the illegal circulation and marketing of the substandard and falsified Knowit Insulin Syringe 40 IU 29G x 1/2 in Nigeria.
"The Association of Community Pharmacists of Nigeria has raised concerns about the ongoing use of 40 IU/ML insulin syringes despite the availability of 100 IU/ML insulin syringes.
"The 40 IU/ML insulin syringe was previously approved alongside the 100 IU/ML variant for administering Lente animal insulins, as they were available in both strengths.
"However, with the discontinuation of animal insulins and the advent of human insulins -- now standardised at 100 IU/ML--the 40 IU/ML insulin syringe is no longer applicable and is no longer registered by NAFDAC. Its use could result in dosing errors, with serious adverse consequences for diabetic patients.
"Using a 40 IU/ML syringe to administer 100 IU/ML insulin exposes patients to a high risk of dosing errors, as the calculations required to adjust for this mismatch cannot be reliably performed by most patients."
To address the issue, NAFDAC directed all its zonal directors and state coordinators to conduct surveillance and remove substandard and falsified insulin syringes from circulation.
It also urged importers, distributors, retailers, healthcare professionals, and caregivers to be vigilant and prevent the importation, distribution, and sale of the product.
