Accupaque Visipaque Batch Risk Alert: Particle Contamination in Iohexol Iodixanol Solutions
Summary
GE Healthcare Buchler GmbH & Co. KG issued a Direct Healthcare Professional Communication (DHPC) alerting to a potential risk of particles in certain batches of Accupaque (iohexol) and Visipaque (iodixanol) solutions for injection filled into polypropylene bottles. The company instructs that only clear, particle-free solutions may be used per the Summary of Product Characteristics (SmPC), and this must be verified prior to administration.
What changed
The manufacturer GE Healthcare Buchler GmbH & Co. KG issued a DHPC notifying healthcare professionals of a potential particle contamination risk in certain batches of Accupaque (iohexol) and Visipaque (iodixanol) contrast agent solutions for injection. The affected products were filled into polypropylene bottles. The DHPC reiterates that per the applicable SmPC, only clear and particle-free solutions may be administered, and this must be confirmed before each use.
Healthcare providers using these contrast agents should verify the integrity and clarity of each vial or bottle prior to administration. If particles are visible, the product must not be used. While this is a targeted batch-level issue rather than a product-wide recall, the risk applies to a critical injectable diagnostic product, warranting verification procedures.
What to do next
- Verify each unit is clear and particle-free before administration per SmPC instructions
- Do not use solutions showing visible particles
- Contact GE Healthcare for information on affected batch numbers
Archived snapshot
Apr 12, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Direct Healthcare Professional Communication (DHPC) on Accupaque solution for injection and Visipaque solution for injection: risk of particles
2026.03.27
Active substance: iohexol, iodixanol
The company GE Healthcare Buchler GmbH & Co. KG informs about the potential risk of particles in certain batches of the two medicinal products Accupaque solution for injection and Visipaque solution for injection, which were filled into polypropylene bottles. The company notes that, in accordance with the respective Summery of Product Characteristics (SmPC), only clear, particle-free solutions may be used, and this must be verified prior to administration.
Download DHPC/Information letter, DownloadVeroeffentlichtAmEN
2026.03.27
PDF, 231KB, File does not meet accessibility standards
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