Safety Recall: Omnipaque and Visipaque Injectable Solutions
Summary
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety recall for specific lots of Omnipaque and Visipaque injectable solutions manufactured by GE Healthcare SAS. The recall is due to the potential presence of particles adhering to the inner wall of the vials, posing a risk to patients if injected.
What changed
ANSM has mandated a safety recall for specific batches of Omnipaque 350 mg d'I/mL and Visipaque 320 mg d'I/mL injectable solutions from GE Healthcare SAS. The recall is prompted by the identification of particles adhering to the internal surface of 100 mL vials. These particles, if not detected prior to administration, could pose a significant risk to patient safety.
Healthcare facilities, pharmaceutical distributors, and healthcare professionals who have received the affected lots must immediately cease distribution and return the products. GE Healthcare SAS has provided contact information for medical and pharmaceutical inquiries. While no adverse events have been reported to date, prompt action is required to mitigate potential patient harm.
What to do next
- Cease distribution of affected lots of Omnipaque and Visipaque.
- Return affected lots to GE Healthcare SAS.
- Contact GE Healthcare France for medical and pharmaceutical inquiries.
Archived snapshot
Mar 26, 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.
Niveau de rappel : établissements de santé et circuit de distribution pharmaceutique, ainsi qu'en direct auprès des professionnels de santé ayant reçu un lot objet du rappel. Le Laboratoire GE Healthcare SAS procède, en accord avec l’ANSM et par mesure de précaution, au rappel des lots mentionnés ci-dessous des spécialités pharmaceutiques :
- Omnipaque 350 mg d'I/mL, solution injectable – flacon de 100 mL (CIP 34009 562 388 1 1)
- Lot 17324090 (Exp oct.-28)
- Lot 17361386 (Exp oct.-28)
- Lot 17364400 (Exp oct.-28)
- Lot 17364401 (Exp nov.-28)
- Visipaque 320 mg d'I/mL, solution injectable – flacon de 100 mL (CIP 34009 352 013 1 7)
- Lot 17264301 (Exp août-28)
- Lot 17264302 (Exp juil.-28)
- Lot 17302277 (Exp août-28)
- Lot 17323156 (Exp août-28) Ce rappel fait suite à la mise en évidence de particules adhérentes à la paroi interne de certains flacons de 100 mL. Si ces particules se détachent et ne sont pas détectées avant l’injection, elles peuvent représenter un risque pour la sécurité des patients.
Le laboratoire précise qu’aucune réclamation qualité ou évènement indésirable en lien avec le défaut qualité observé n’ont été rapportés à ce jour.
Pour toute question médicale ou pharmaceutique sur ces médicaments, vous pouvez contacter le service Information Médicale de GE Healthcare France à l’adresse suivante : infomedfrance@gehealthcare.com.
Niveau de rappel : établissements de santé et circuit de distribution pharmaceutique, ainsi qu'en direct auprès des professionnels de santé ayant reçu un lot objet du rappel.
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