NAFDAC flags dangerous CT scan dye used in hospitals

By Precious Mark

The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public alert warning healthcare providers and members of the public about substandard batches of iodinated contrast media used in diagnostic imaging procedures, following a global safety notice issued by the World Health Organization (WHO).

NAFDAC, in Public Alert No. 26/2026, identified the affected products as Accupaque (Iohexol), Omnipaque (Iohexol), and Visipaque (Iodixanol), which are injectable contrast media used in CT scans and other interventional medical procedures to improve the clarity of medical imaging.

NAFDAC further clarified that Omnipaque 350mg/ml and 300mg/ml injections are registered for use in Nigeria, with registration numbers NRN: B4-0328 and B4-0329 respectively.

However, it noted that Visipaque is not registered in Nigeria.

According to the agency, the alert follows reports from the Health Products Regulatory Authority (HPRA) in Ireland, which in March 2026 notified the WHO of quality concerns involving specific batches manufactured by GE HealthCare Ireland Limited.

NAFDAC explained that the issue involves a Class I quality defect, the most serious category of product quality failure, linked to the presence of metallic particulate matter found on the inner surface of 100ml polypropylene (plastic) bottles. The manufacturer also confirmed the presence of free metallic particles within the finished product.

The agency stressed that the defect is limited only to products packaged in 100ml plastic containers, adding that glass-packaged versions are not affected.

The affected products, according to the alert, have already been distributed globally and supplied mainly to hospitals, including facilities that carry out radiology, cardiology, and vascular surgical procedures, where contrast media are routinely used.

NAFDAC warned that these products are administered intravenously or intra-arterially, and the presence of metallic particles could pose serious health risks.

The agency noted that intra-arterial use, in particular, could lead to severe complications, including life-threatening embolic events, where particles obstruct blood vessels and disrupt blood flow.

“To prevent patient harm, it is important to identify and remove the affected batches of Accupaque, Omnipaque, and Visipaque from clinical use,” the agency cautioned.

NAFDAC said it has directed all zonal directors and state coordinators to intensify surveillance and conduct mop-up operations to remove any affected products found within their jurisdictions.

The agency also urged importers, distributors, retailers, healthcare professionals, and caregivers to exercise heightened vigilance across the supply chain.

It advised that all medical products must be sourced strictly from authorized and licensed suppliers, while stressing the importance of verifying product authenticity and physical condition before use.