The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted healthcare providers and the general public to multiple batches of substandard Accupaque, Omnipaque, and Visipaque injection solutions packaged in 100 ml polypropylene containers and identified in Ireland.
According to NAFDAC, the development was reported to the World Health Organization (WHO) by the Health Products Regulatory Authority (HPRA) of Ireland in March 2026.
In a public alert issued on Thursday, NAFDAC disclosed that a Class I quality defect was detected in specific batches of iodinated contrast media (Iohexol or Iodixanol) marketed under the brand names Accupaque, Omnipaque, and Visipaque and manufactured by GE HealthCare Ireland Limited.
The agency noted that the defect involves metallic particulate matter found on the inner surface of 100 ml polypropylene (plastic) bottles, adding that the manufacturer also confirmed the presence of free metallic particles within some finished products.
NAFDAC explained that the quality defect affects only batches supplied in 100 ml plastic containers, while products packaged in glass containers are not affected.
It also stated that the affected products had been distributed globally to several countries, primarily to hospitals and healthcare facilities carrying out interventional radiology, cardiology, and vascular surgery procedures.
NAFDAC warned that the products are intended for intra-arterial and intravenous administration and that the presence of particulate matter poses significant health risks to patients.
“The presence of particulate matter poses a safety risk, especially when injected intra-arterially, and can cause serious adverse events, including life-threatening embolic events,” the agency warned.
To prevent potential harm to patients, NAFDAC urged healthcare facilities and professionals to identify and immediately remove all affected batches of Accupaque, Omnipaque, and Visipaque from clinical use.
The agency further disclosed that Omnipaque 350 mg/ml and 300 mg/ml injections are registered for use in Nigeria under registration numbers B4-0328 and B4-0329, respectively, while Visipaque is not registered in the country.
As part of its response measures, NAFDAC ordered its zonal directors and state coordinators to intensify surveillance activities and mop up any affected products found within their jurisdictions.
The agency also advised importers, distributors, retailers, healthcare professionals, and caregivers to exercise vigilance throughout the supply chain to prevent the importation, distribution, sale, and use of the affected products.
NAFDAC stressed that all medical products should be sourced only from authorised and licensed suppliers and that their authenticity and physical condition should be carefully verified before use.
The agency encouraged healthcare professionals and consumers to report any suspected sale or distribution of substandard or falsified medicines and medical devices to its nearest office, through toll-free number 0800-162-3322, or via email at sf.alert@nafdac.gov.ng.
It also urged healthcare professionals and patients to report adverse drug reactions and side effects through its e-reporting platforms, the Med Safety mobile application, or by email to pharmacovigilance@nafdac.gov.ng.
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