
The agency has recalled six lots of GE Healthcare's X-ray contrast agent due to a risk to patient safety.
Roszdravnadzor has recalled six batches of the Irish diagnostic drug Omnipaque produced by GE Healthcare due to dangerous metal particles in the bottles.
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Roszdravnadzor has identified risks for patients due to metal particles in vials of the drug from GE Healthcare.
Roszdravnadzor has recalled six batches of the Irish drug Omnipaque from GE Healthcare due to the presence of dangerous metal particles that pose a risk to patient safety, according to an information letter from the department, which was reviewed by RIA Novosti.
"Omnipak" is a radiocontrast agent, its active ingredient is iohexol. The drug is used exclusively for diagnostic purposes to make the image of internal organs and tissues in pictures (x-rays, CT) clearer and more detailed.
"A product recall related to potential particulate matter in polypropylene bottles of Omnipaque 100 ml... from GE Healthcare. It has been learned that some bottles of Omnipaque 100 ml may have particulate matter in polypropylene bottles. If these particles become detached and are not detected prior to administration, they may pose a risk to patient safety," the statement reads. document.

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