ALERT: NAFDAC raises alarm over circulation of substandard insulin syringes

• The agency emphasised that unregistered syringes must not be imported, distributed, or sold to protect public health and ensure proper insulin administration.

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued an alert regarding the unlawful distribution and sale of a falsified medical product, Knowit Insulin Syringe 40 IU 29g X 1/2 in the country.

The agency released a statement on Monday, citing concerns raised by the Association of Community Pharmacists of Nigeria about the continued use of outdated 40 IU/ML insulin syringes despite the availability of the standard 100 IU/ML syringes.

NAFDAC also cautioned that the syringe is no longer registered and its continued usage presents a significant risk of dosing mistakes, which may cause severe health 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of animal insulins and the advent of human insulins — now standardised at 100 IU/ML—the 40 IU/ML insulin syringe is no longer applicable and is no longer registered by NAFDAC.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 combat the situation, NAFDAC instructed all its zonal directors and state coordinators to carry out inspections and eliminate any substandard or falsified insulin syringes from the market.

The agency also called on importers, distributors, retailers, healthcare providers, and caregivers to stay alert and prevent the importation, distribution, and sale of the unapproved product.