Class II · Moderate risk
GE Healthcare Omnipaque
Presence of particulate matter
Omnipaque (iohexol)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was 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.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
0407-1411-20
Compare with the code on your package — it is the most precise check available.
Drug: Iohexol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Omnipaque Iohexol NDC 00407-1411 |
180 mg/mL | Injection, Solution Intrathecal|oral|rectal |
GE Healthcare Inc. | Rx |
- Recalling firm
- GE Healthcare Inc. Life Sciences
- NDC code
- 0407-1411-20
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0319-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iohexol recalls
See all
Class II · Moderate risk
GE Healthcare Omnipaque
Presence of particulate matter
Class I · High risk
Iohexol (300 mg Iodine/mL)
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Class II · Moderate risk
Iohexol
Lack of Assurance of Sterility
Class II · Moderate risk
Iopamidol 41% Injectable 198 Ml 99 Ml 50 Ml 600 Ml 72 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Other packaging defect recalls from 2018
All packaging defect recalls
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Class III · Low risk
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Class II · Moderate risk
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