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.
FDA recall notice · announced December 26, 2018 · Ge Healthcare Inc. Life Sciences
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Notes
Distribution: TN
Lot/code information: Lot #: 14301544, Exp 21Sep21
Quantity: 1092 cartons
Status: Terminated
Products in this recall event:
- 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 (D-0319-2019)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.