Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Omnipaque (iohexol) Injection Recalled by GE Healthcare Inc. Life Sciences Due to Defective Container: vial defect was identified that could...

Date: October 29, 2018
Company: GE Healthcare Inc. Life Sciences
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Healthcare Inc. Life Sciences directly.

Affected Products

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.

Quantity: 1092 cartons

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: TN

Affected (1 state)Not affected

About GE Healthcare Inc. Life Sciences

GE Healthcare Inc. Life Sciences has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report