CLASS II Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Omnipaque (iohexol) Injection, 180mgI/mL Single-Dose Vial recalled
GE Healthcare Inc. Life Sciences is recalling Omnipaque (iohexol) Injection, 180mgI/mL Single-Dose Vial, distributed in Tennessee. The recall was initiated on 29 Oct 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0319-2019
- FDA event ID
- 81691
- Recalling firm
- GE Healthcare Inc. Life Sciences, Marlborough, MA
- Brand
- Omnipaque
- Manufacturer
- GE Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Oct 2018
- FDA classified
- 14 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Oct 2018 | Recall initiated by company | |
| 14 Dec 2018 | Classified by FDA | +46 days |
| 26 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Product as listed by the FDA
Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20.
Where it was distributed
TN
Questions about this recall
Why was it recalled?
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Which lots are affected?
Lot #: 14301544, Exp 21Sep21
Where was it sold?
TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Iohexol recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%) recalledOmnipaque | GE Healthcare Irel | Particulate Matter | Nationwide |
| Drug | CLASS II | GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%) recalledOmnipaque | GE Healthcare Irel | Particulate Matter | Nationwide |