Omnipaque (iohexol) Injection…

Date

Dec. 26, 2018

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare Inc. Life Sciences

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

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

Quantity

1092 cartons

Codes and lots

Lot #: 14301544, Exp 21Sep21

Recall started

Oct. 29, 2018

Recall number

D-0319-2019

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-0319-2019. The agency record governs; check it and the company before acting.