Recalls / Class II
Class IID-0319-2019
Product
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.
- Brand name
- Omnipaque
- Generic name
- Iohexol
- Active ingredient
- Iohexol
- Route
- Intravascular, Intravenous
- NDCs
- 0407-1401, 0407-1411, 0407-1412, 0407-1413, 0407-1414, 0407-1415, 0407-1416
- FDA application
- NDA018956
- Affected lot / code info
- Lot #: 14301544, Exp 21Sep21
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.
Recalling firm
- Firm
- GE Healthcare Inc. Life Sciences
- Manufacturer
- GE Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Results Way, Marlborough, Massachusetts 01752-3078
Distribution
- Quantity
- 1092 cartons
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2018-10-29
- FDA classified
- 2018-12-14
- Posted by FDA
- 2018-12-26
- Terminated
- 2023-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0319-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.