FDAFDA · Food and drugs·Recall number D-0319-2019
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.
Published December 26, 2018 · Recall initiated: October 29, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- OMNIPAQUE
- Manufacturer
- GE Healthcare Inc. Life Sciences
- Distributor
- TN
- Lot
- Lot #: 14301544, Exp 21Sep21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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