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, Dis…

Recall date

October 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0319-2019

FDA classification

Class II

Brand / firm

GE Healthcare Inc. Life Sciences

Sold / distributed

TN

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.