NAFDAC issues warning on substandard insulin product in Nigeria

NIGERIA—The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a stern warning regarding the illegal circulation and marketing of a substandard, falsified medical product in Nigeria.

 The product in question is the Knowit Insulin Syringe 40 IU 29G x 1/2, which, according to the agency, poses significant risks to diabetic patients.

This announcement follows growing concerns from the Association of Community Pharmacists of Nigeria about the continued use of outdated 40 IU/ML insulin syringes, even though a safer, standardised 100 IU/ML alternative is widely available.

Previously, the 40 IU/ML syringes were approved for use when both animal and human insulins were available.

At that time, the dual strength allowed healthcare providers to administer Lente animal insulins, which were offered in two different concentrations.

However, as the market shifted toward human insulins—now uniformly standardised at 100 IU/ML—the 40 IU/ML syringes have become obsolete. NAFDAC has made it clear that these syringes are no longer registered for use, and their continued distribution can lead to serious dosing errors.

The agency’s statement highlights that using a 40 IU/ML syringe for administering 100 IU/ML insulin significantly increases the risk of miscalculation.

Most patients would find it challenging to accurately adjust the dose, which can result in either an overdose or an insufficient dose.

Both scenarios carry potentially life-threatening consequences, especially for individuals who depend on precise insulin administration to manage their blood sugar levels.

In response to these risks, NAFDAC has directed all zonal directors and state coordinators to intensify surveillance measures.

Their mandate is to identify and remove any stocks of the falsified Knowit Insulin Syringe from circulation.

This proactive step is aimed at preventing further harm to patients and ensuring that only safe, approved medical devices are available in the market.

Furthermore, the agency has urged all importers, distributors, retailers, healthcare professionals, and caregivers to exercise heightened vigilance.

They are called upon to refrain from the importation, distribution, and sale of the outdated product.

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