WHO has issued a global medical product alert for substandard batches of ACCUPAQUE, OMNIPAQUE and VISIPAQUE, warning of metallic particulate contamination and telling users to remove affected stock from clinical use.
The World Health Organization has issued a global Medical Product Alert warning about substandard batches of three contrast media products: ACCUPAQUE, OMNIPAQUE and VISIPAQUE.
WHO said the affected batches are linked to metallic particulate matter and should be removed from clinical use. The alert covers specific products containing iohexol and iodixanol supplied in 100 ml polypropylene containers.
According to WHO, the problem involves at least one confirmed free particulate found in finished product. The agency said glass containers are not affected.
The alert escalates earlier national recalls and safety notices in Europe. Ireland's HPRA issued a recall on March 23 for Omnipaque and Visipaque batches, Austria's BASG posted a recall on March 25, and German drug-safety communications followed on March 27.
WHO said the affected batches were supplied globally. The agency's warning is intended to help health workers and procurement teams identify, isolate and remove the products from use.
The full batch list is included in WHO's alert and national regulators have already been asked to follow up. WHO has not reported confirmed patient harm in the sources reviewed for this report.
Hospitals and clinics using contrast media are being urged to check stock against the alert and rely on official regulatory notices for batch-specific instructions.
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