Warning
GE Healthcare Ireland Limited Recalls GE Healthcare Omnipaque (iohexol) Injection
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0447-2026Drug / Pharmaceutical
GE Healthcare Ireland Limited Recalls GE Healthcare Omnipaque (iohexol) Injection
GE Healthcare Ireland Limited · Class II — Moderate Risk
Product Description
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Reason for Recall
Presence of particulate matter
FDA Classification
Class II — Moderate Risk
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.
Distribution
U.S. Nationwide.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database