D-0319-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 26, 2018
- Initiation Date
- October 29, 2018
- Termination Date
- October 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1092 cartons
Product Description
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.
Distribution Pattern
TN
Code Information
Lot #: 14301544, Exp 21Sep21