GE HealthCare has said its iodinated contrast supply remains stable after a quality alert involving certain contrast media batches packaged in 100 mL polypropylene containers.
WHO issued a Medical Product Alert on May 7 for multiple batches of Accupaque, Omnipaque, and Visipaque solutions for injection. The products were manufactured by GE HealthCare Ireland in Cork.
Ireland’s Health Products Regulatory Authority notified WHO in March of a Class 1 quality defect affecting specific batches of iohexol and iodixanol contrast media, according to the alert.
Metallic particulate matter was found either adhered to or embedded within the inner surface of polypropylene bottles, WHO said. At least 1 confirmed instance involved free metallic particulate within a finished product.
Batches supplied in glass containers are not affected, according to WHO. The alert said affected batches were supplied globally.
GE HealthCare said in a statement provided to the source article that the bottle-supplier issue has been resolved and that alternative stock-keeping units are meeting customer demand in most cases.
A U.K. direct healthcare professional communication for Omnipaque and Visipaque advised users to visually inspect parenteral products for particulate matter, discoloration, and container integrity before use.
GE HealthCare announced in January 2025 that it would invest $138M in its Cork contrast-media manufacturing site. The company said the expansion was expected to add 25M patient doses per year by the end of 2027.
Company:GE HealthCare
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