NAFDAC Raises Alarm Over Defective Injection Products

The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers and the public to the circulation of multiple batches of substandard contrast injection products linked to potentially life-threatening health risks.

The agency said the affected products include certain batches of ACCUPAQUE, OMNIPAQUE and VISIPAQUE solutions for injection manufactured by GE HealthCare Ireland Limited and supplied to several countries across the world.

In a public alert issued on its official X handle on Thursday, NAFDAC disclosed that the products were flagged following a report from the Health Products Regulatory Authority (HPRA) of Ireland to the World Health Organisation (WHO) in March 2026.

According to the agency, investigations revealed a Class I quality defect involving the presence of metallic particulate matter on the inner surface of some 100ml polypropylene containers used for the products.

The manufacturer was also reported to have confirmed the presence of free metallic particles within affected products.

NAFDAC warned that the defect poses serious safety concerns because the products are administered through intravenous and intra-arterial injection.

“The presence of particulate matter poses a safety risk, especially when injected intra-arterially, and can cause serious adverse effects, including life-threatening embolic events,” the agency stated.

It explained that the defect affects only batches supplied in 100ml plastic containers, while products packaged in glass containers are not affected.

The agency noted that the products are commonly used in hospitals and specialist healthcare facilities, particularly during radiology, cardiology and vascular surgery procedures.

While Omnipaque 350mg/ml and 300mg/ml injections are registered for use in Nigeria, NAFDAC said Visipaque is not registered in the country.

To prevent potential harm to patients, the agency directed all its zonal directors and state coordinators to intensify surveillance activities and immediately remove any affected batches found within their jurisdictions.

NAFDAC also urged importers, distributors, retailers, healthcare professionals and caregivers to exercise caution throughout the supply chain and ensure that all medical products are sourced only from authorised and licensed suppliers.

The agency advised healthcare institutions and consumers to carefully verify the authenticity and physical condition of medical products before use.

It further stated that details of the affected batches and products have been published on its website and urged healthcare providers and members of the public to consult the information for identification and verification purposes.

NAFDAC encouraged anyone who encounters suspected substandard or falsified medicines and medical devices to report them to the nearest agency office or through its designated reporting channels.

The agency also called on healthcare professionals and patients to promptly report adverse reactions, side effects or safety concerns associated with medicinal products through its pharmacovigilance platforms.

The warning forms part of ongoing efforts by NAFDAC to strengthen medicine safety surveillance and protect Nigerians from potentially harmful medical products.