Medications & Supplements/Prescription Drugs

Fresenius Kabi USA, LLC: Midazolam Injection Recalled for Label Mix-Up with Ondansetron

Agency Publication Date: January 4, 2018

Summary

Fresenius Kabi USA, LLC has recalled 203,136 syringes of Midazolam Injection, USP (2 mg / 2 mL). While the outer blister packaging is labeled as Midazolam, the syringes inside actually contain Ondansetron Injection, USP (4 mg / 2 mL). This medication was distributed nationwide in the United States in cartons containing 24 prefilled single-use syringes.

Risk

A label mix-up can lead to a patient receiving the wrong medication; specifically, receiving the anti-nausea drug ondansetron when a sedative like midazolam is expected. This can result in a lack of necessary sedation during medical procedures or the unintended administration of ondansetron, which may cause adverse reactions or delay critical treatment.

What You Should Do

Check your medical supplies for Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL) in 24-count cartons (NDC 76045-001-20).
Verify the lot number on the packaging; this recall specifically affects lot number 6400048.
Inspect the individual syringes inside the blister packs to see if the labeling on the syringe itself matches the outer package (Midazolam) or if it incorrectly identifies the contents as Ondansetron Injection, USP, 4 mg / 2 mL.
If you have the affected product, stop using it immediately and contact your healthcare provider or pharmacist for guidance on how to manage your medication supply.
Return any unused syringes from the affected lot to the pharmacy or place of purchase for a refund and contact Fresenius Kabi USA, LLC for further instructions regarding the return process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider and return product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton

Model:

NDC 76045-001-20

Lot Numbers:

6400048

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78396

Status: Resolved

Manufacturer: Fresenius Kabi USA, LLC

Manufactured In: United States

Units Affected: 203136 syringes

Distributed To: Nationwide

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 · 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.

Summary

Risk

What You Should Do

Check your medical supplies for Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL) in 24-count cartons (NDC 76045-001-20).

Verify the lot number on the packaging; this recall specifically affects lot number 6400048.

Inspect the individual syringes inside the blister packs to see if the labeling on the syringe itself matches the outer package (Midazolam) or if it incorrectly identifies the contents as Ondansetron Injection, USP, 4 mg / 2 mL.

If you have the affected product, stop using it immediately and contact your healthcare provider or pharmacist for guidance on how to manage your medication supply.

Return any unused syringes from the affected lot to the pharmacy or place of purchase for a refund and contact Fresenius Kabi USA, LLC for further instructions regarding the return process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).