NIGERIA: NAFDAC Raises Alarm Over Illegal Circulation Of Banned Insulin Syringe

By Onoja Baba, Nigeria  

The National Agency for Food and Drug Administration and Control, NAFDAC, has sounded the alarm over the illegal circulation of a banned and substandard medical product, the Knowit Insulin Syringe 40 IU 29G x 1/2, in Nigeria.

The agency raised the alert in a public statement published on its official website on Monday, following concerns from the Association of Community Pharmacists of Nigeria regarding the continued use of the outdated 40 IU/ML insulin syringes despite the availability of the recommended 100 IU/ML syringes.

According to NAFDAC, the 40 IU/ML insulin syringe was initially approved alongside the 100 IU/ML variant when Lente animal insulins were still in use, as both types of insulin were available in these two strengths.

However, following the complete transition from animal insulins to human insulins, which are standardised at 100 IU/ML, the 40 IU/ML syringes became obsolete.

The agency noted that the continued use of the outdated syringe poses a significant threat to diabetic patients due to the risk of dangerous dosing errors.

NAFDAC explained that the 40 IU/ML syringes are no longer registered in Nigeria, and using them to administer the now-standard 100 IU/ML insulin can lead to serious dosing miscalculations.

The agency stressed that these errors could result in life-threatening complications, including severe hypo- or hyperglycemia.

The agency warned that most diabetic patients, particularly those managing their care at home, may not be able to correctly adjust doses to account for the mismatch, putting their health and lives at risk.

To address the threat, NAFDAC has ordered its zonal directors and state coordinators to intensify surveillance across the country to identify and remove all substandard and falsified insulin syringes from the market.

The agency also urged importers, wholesalers, retailers, pharmacists, healthcare workers, and caregivers to exercise extreme caution in sourcing insulin syringes, ensuring only approved 100 IU/ML syringes are purchased and used.

NAFDAC reiterated its commitment to protecting public health by eliminating substandard medical products from Nigeria’s healthcare system and ensuring diabetic patients have access to safe and effective insulin delivery devices.