GE Healthcare Inc. Life Sciences recalls Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Dist
Recalled December 26, 2018 · FDA recall D-0319-2019 · GE Healthcare Inc. Life Sciences
Hazard
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. · FDA Class II
Units
1092 cartons
Sold at
TN
Description
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.
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.
Manufacturer(s)
GE Healthcare Inc. Life Sciences
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →