Medications & Supplements/Prescription Drugs

Baxter Healthcare Corporation: Nexterone (amiodarone HCl) Injection Recalled for Polyethylene Particulates

Agency Publication Date: February 1, 2018

Summary

Baxter Healthcare Corporation is recalling 35,628 units of Nexterone (amiodarone HCl) Premixed Injection, a medication used to treat heart rhythm disorders. The recall was initiated because particulate matter, specifically polyethylene plastic from the manufacturing bag and ports, was found inside the product. Consumers who have this medication should contact their healthcare provider or pharmacist immediately, as the presence of plastic particles in an intravenous drug can cause serious health complications.

Risk

If plastic particles are injected into the bloodstream, they can cause inflammation, block blood vessels, or travel to vital organs like the lungs, heart, or brain, potentially leading to a stroke, heart attack, or death.

What You Should Do

Check your medication to see if it is Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL in 100-mL bags (NDC 43066-150-10).
Look for Lot # NC109925 with expiration date 6/1/2019 or Lot # NC109123 with expiration date 5/2019 on the product packaging.
If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance and to obtain a replacement.
Return any unused or affected medication to the pharmacy where you purchased it for a refund.
Contact Baxter Healthcare Corporation directly at their Deerfield, Illinois headquarters if you have further questions regarding this recall.
For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

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

Affected Products

Product: Nexterone (amiodarone HCl) Premixed Injection (100-mL bag)

Model:

NDC 43066-150-10

Recall #: D-0573-2018

Lot Numbers:

NC109925 (Exp 6/1/2019)

NC109123 (Exp 5/2019)

Date Ranges: Expiration date 6/1/2019, Expiration date 5/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78531

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Manufactured In: United States

Units Affected: 35,628 single-dose containers

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

What You Should Do

Check your medication to see if it is Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL in 100-mL bags (NDC 43066-150-10).

Look for Lot # NC109925 with expiration date 6/1/2019 or Lot # NC109123 with expiration date 5/2019 on the product packaging.

If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance and to obtain a replacement.

Return any unused or affected medication to the pharmacy where you purchased it for a refund.

Contact Baxter Healthcare Corporation directly at their Deerfield, Illinois headquarters if you have further questions regarding this recall.

For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.