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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

GE Healthcare Inc. Life Sciences: Omnipaque (iohexol) Injection Recalled for Potential Lack of Sterility

Agency Publication Date: December 14, 2018
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Summary

Approximately 1,092 cartons of Omnipaque (iohexol) Injection, 180mgI/mL, are being recalled because a defect was found in the 20 mL single-dose glass vials. This defect can compromise the container's seal and may lead to the presence of glass particles or a lack of sterility in the medication. Consumers should be aware that this affects 10-vial cartons of the 20 mL size, specifically from lot 14301544.

Risk

A compromised vial seal can allow bacteria to enter the medication, leading to serious infections. Additionally, the presence of glass particles in an injectable drug can cause local irritation, inflammation, or more severe complications if the particles travel through the bloodstream.

What You Should Do

  1. Check your medical supplies for Omnipaque (iohexol) Injection, 180mgI/mL, in 20 mL single-dose vials, which are packaged 10 vials per carton.
  2. Identify if your product is affected by looking for NDC number 0407-1411-20 and Lot Number 14301544 with an expiration date of 21Sep21 (September 21, 2021).
  3. Immediately stop using any vials from the affected lot and set them aside to ensure they are not administered to patients.
  4. Contact your healthcare provider or pharmacist for guidance regarding this recall and to discuss alternative medication options.
  5. Return any unused or remaining product from this lot to the pharmacy or place of purchase for a refund.
  6. Contact GE Healthcare Inc. Life Sciences at their Marlborough, MA location for further instructions on returning the product.
  7. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Omnipaque (iohexol) Injection, 180mgI/mL (20 mL Single-Dose Vial)
Model:
NDC 0407-1411-20
Recall #: D-0319-2019
Lot Numbers:
14301544 (Exp 21Sep21)
Date Ranges: Expiration date September 21, 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81691
Status: Resolved
Manufacturer: GE Healthcare Inc. Life Sciences
Sold By: Hospitals; Clinics; Medical distributors
Manufactured In: United States, Norway
Units Affected: 1092 cartons
Distributed To: Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.