Drug recall D-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.
Reason for recall
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.
Lots and codes
Lot #: 14301544, Exp 21Sep21
Recall details
- Recalling firm
- GE Healthcare Inc. Life Sciences, Marlborough, MA
- Quantity
- 1092 cartons
- Distribution
- TN
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 29, 2018
- Terminated
- October 30, 2023
Related products
- Omnipaque – drug information
- NDC 0407-1411 Omnipaque · Iohexol 180 mg/mL · GE Healthcare Inc.
- NDC 0407-1415 Omnipaque · Iohexol 9 mg/mL · GE Healthcare Inc.
- NDC 0407-1401 Omnipaque · Iohexol 140 mg/mL · GE Healthcare Inc.
- NDC 0407-1413 Omnipaque · Iohexol 300 mg/mL · GE Healthcare Inc.
- NDC 0407-1412 Omnipaque · Iohexol 240 mg/mL · GE Healthcare Inc.
- NDC 0407-1414 Omnipaque · Iohexol 350 mg/mL · GE Healthcare Inc.
- NDC 0407-1416 Omnipaque · Iohexol 12 mg/mL · GE Healthcare Inc.