Class II · Moderate risk
GE Healthcare Omnipaque
Presence of particulate matter
Iohexol
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5
Affected NDC
71283-1413-05
Compare with the code on your package — it is the most precise check available.
Drug: Iohexol
- Recalling firm
- Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- NDC code
- 71283-1413-5
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0979-2020 · 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
Omnipaque (iohexol)
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.
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 recalls by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
All 2020 recalls
Class II · Moderate risk
Zinc Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Cholecalciferol
Lack of Assurance of Sterility
Class II · Moderate risk
Triamcinolone Diacetate Injectable Suspension
Lack of Assurance of Sterility
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