Drug 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.
D-0319-2019
Product summary
- Event
- Event 81691
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1092 cartons
- Official record key
drug-enforcement:D-0319-2019
Official wording
Reason: 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.
Code information: Lot #: 14301544, Exp 21Sep21
Distribution pattern: TN
Derived failure modes
-
Foreign material or chemical contamination
glass particles
-
Sterility assurance
lack of sterility