Baxter Nexterone Amiodarone Injection Recall: Particulate Matter Hazard
Baxter Healthcare recalls Nexterone amiodarone injections due to polyethylene particles in the packaging. This could cause serious injury if injected. Affected units have specific NDC and lot numbers.
Stop using this now
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
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What happened, in plain English
Baxter Healthcare is recalling Nexterone amiodarone injections because they contain polyethylene particles from the packaging. This risk could cause serious injury if the injection is administered. Read more at govinfonow.com/recall/41100-baxter-nexterone-amiodarone-injection-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/41100-baxter-nexterone-amiodarone-injection-recall-particulate-matter-hazard · Updated October 7, 2026 · FDA enforcement record: FDA #D-0573-2018
Cite this page
“Baxter Nexterone Amiodarone Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41100-baxter-nexterone-amiodarone-injection-recall-particulate-matter-hazard. Based on FDA recall #D-0573-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0573-2018%22&limit=1).
Why it’s dangerous
Polyethylene particles from the injection bag's film and ports can enter the medication. When injected, these particles may cause serious injury or death due to the body's reaction to foreign material.
Who’s affected
Healthcare professionals who use this medication for cardiac treatments. Patients receiving this injection under medical supervision are at risk if the product is used.
How to tell if you have this one
Check for NDC code 43066-150-10 and lot numbers NC109925 (expires 6/1/2019) or NC109123 (expires 5/2019). The product is a sterile, premixed injection for medical use only.
- Brand
Baxter Healthcare- Category
Drug
What to do — step by step
Stop Using Now
Immediately stop using the recalled Nexterone injection if you have it.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0573-2018 (November 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0573-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.