Omnipaque Visipaque 100ml Batch Recall Particles
Summary
HPRA Ireland has issued a user-level batch recall for specific lots of Omnipaque 350 mg I/ml Solution for Injection and Visipaque 320 mg I/ml Solution for Injection due to potential particle contamination in 100ml polypropylene bottles. Affected batches are Omnipaque lot 17413362 (expiry 15.10.2028) and Visipaque lot 17230467 (expiry 14.08.2028), both authorised to GE Healthcare AS. Glass bottle presentations are not affected. Pharmacists must quarantine stock, complete the recall form, and notify relevant healthcare facilities.
What changed
HPRA Ireland has issued a user-level batch recall affecting two specific production batches of contrast media solutions distributed in 100ml polypropylene bottles. The recall identifies particle contamination as the root cause and applies to Omnipaque batch 17413362 and Visipaque batch 17230467. Glass bottle presentations of these products are explicitly excluded from the recall scope.
Pharmacists and healthcare facilities must immediately quarantine affected stock across all locations including wards and clinics, return the product via GE Healthcare using the attached form, and propagate recall notifications to any downstream healthcare facilities that received units from these batches. Patients and public are not required to take action but may contact their pharmacist for queries.
What to do next
- Immediately identify and quarantine any packs from the above-listed batches within your facility.
- Please complete and return the form attached to the Recall letter by emailing it to Recall.89013@gehealthcare.com.
- Please make all relevant health care professionals aware of the contents of the recall letter.
- If you have supplied units from the above listed batches to any other hospital, healthcare facility or user, please notify them of this recall action.
Archived snapshot
Apr 20, 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.
Omnipaque 350 mg I/ml Solution for Injection and Visipaque 320 mg l/ml Solution for Injection, - Batch Recall
23/03/2026 Medicines for human use Recall
We wish to advise you that the below listed batches of Omnipaque 350 mg I/ml Solution for Injection and Visipaque 320 mg l/ml Solution for Injection are being recalled with immediate effect.
This recall action is to user level.
The recall is due to the potential presence of particles in 100ml polypropylene bottles in certain batches of the products. Glass bottle presentations are not affected by this defect.
The recall letter, dated 20th March 2026, can be downloaded in the Documents section at the bottom of this webpage.
Product information
Product name Omnipaque 350 mg I/ml Solution for Injection
Visipaque 320 mg l/ml Solution for Injection Authorisation holder GE Healthcare AS Authorisation number PA 0735/006/020, PA 0735/009/013
Serial or batch number and expiry date Omnipaque 350 mg I/ml Solution for Injection, PA 0735/006/020,
Batch number: 17413362 Expiry Date: 15.10.2028
Visipaque 320 mg l/ml Solution for Injection, PA 0735/009/013,
Batch number: 17230467 Expiry Date: 14.08.2028
Human or veterinary medicine Human Medicine Target audience Pharmacists Recall level User level
Actions to be taken
Information for Pharmacists
Pharmacists are requested to perform the following actions:
- Immediately identify and quarantine any packs from the above-listed batches within your facility. This includes stock at all locations within your pharmacy or facility, including at ward level or clinics.
- Please complete and return the form attached to the Recall letter (in the Documents section at the bottom of this page) by emailing it to Recall.89013@gehealthcare.com. GE Healthcare will arrange for product return.
- Please make all relevant health care professionals aware of the contents of the recall letter (in the Documents section at the bottom of this page).
- If you have supplied units from the above listed batches to any other hospital, healthcare facility or user, please notify them of this recall action and forward them a copy of the recall letter (in the Documents section at the bottom of this page).
Information for Patients and Public
No action is required by patients and public. If you have any queries, please contact your pharmacist or healthcare provider.
Documents
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