The National Agency for Food and Drug Administration and Control 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 its website on Monday.
According to the statement, the alarm follows concerns from the Association of Community Pharmacists of Nigeria regarding the continued use of outdated 40 IU/ML insulin syringes, despite the availability of the standardized 100 IU/ML syringes.
NAFDAC explained that the 40 IU/ML insulin syringe was previously approved alongside the 100 IU/ML variant for administering Lente animal insulins, which were available in both strengths. However, with the phasing out of animal insulins and the transition to human insulins—standardized at 100 IU/ML—the 40 IU/ML syringe has become obsolete.
The agency stressed that this syringe is no longer registered, as its use with modern insulin formulations poses a significant risk of dosing errors, potentially leading 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of animal insulins and the advent of human insulins — now standardized at 100 IU/ML—the 40 IU/ML insulin syringe is no longer applicable and is no longer registered by NAFDAC.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.”
NAFDAC stressed that insulin dosing errors are life-threatening and could cause severe complications for diabetic patients.
The agency has directed all its zonal directors and state coordinators to conduct surveillance and remove substandard and falsified products from circulation.
It also urged importers, distributors, retailers, healthcare professionals, and caregivers to exercise caution and vigilance within the supply chain to prevent the importation, distribution, sale, and use of substandard and falsified products.
