GE Healthcare Recalls Omnipaque Injection Due to Vial Defect
GE Healthcare is recalling 1,092 cartons of Omnipaque (iohexol) Injection in Tennessee due to a vial defect that could compromise sterility or introduce glass particles.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves potential loss of sterility and glass particles, which are significant risks, but the source text does not report any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
GE Healthcare Inc. Life Sciences is recalling 1,092 cartons of Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vials. The affected product is Lot #14301544, with an expiration date of September 21, 2021. The recall is limited to distribution in Tennessee.
The recall was initiated because a vial defect was identified that could potentially impact the container closure. This defect may result in a lack of sterility assurance and/or the potential for glass particles in the product. The product is a prescription-only radiographic contrast agent administered intravascularly or intravenously.
Healthcare providers and facilities in Tennessee should check their inventory for the specific lot number and stop using the affected vials. Patients who have received this specific lot of medication should contact their healthcare provider for guidance.
The recalled product
- Product
- OMNIPAQUE (IOHEXOL)
- Brand
- OMNIPAQUE
- Manufacturer
- GE Healthcare Inc. Life Sciences
- Affected units
- 1,092
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 14301544
- Exp 21Sep21
Distribution
Distributed in 1 state:
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