GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.

Recall Number: D-0448-2026

Firm: GE Healthcare Ireland Limited

Classification: Class II

Status: Ongoing

Report Date: 20260415

Initiation Date: 20260324

Termination Date:

Reason for Recall

Presence of particulate matter

Product Description

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.