CLASS I Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Nexterone (amiodarone HCl) Premixed Injection, 150mg recalled
Baxter Healthcare is recalling Nexterone (amiodarone HCl) Premixed Injection, 150mg, distributed nationwide in the US. The recall was initiated on 10 Nov 2017 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0573-2018
- FDA event ID
- 78531
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Brand
- Nexterone
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Nov 2017
- FDA classified
- 1 Mar 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Nov 2017 | Recall initiated by company | |
| 7 Feb 2018 | Published in enforcement report | +89 days |
| 1 Mar 2018 | Classified by FDA | +22 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Where it was distributed
Nationwide within USA and Puerto Rico
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
Where was it sold?
Nationwide within USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Amiodarone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nexterone (amiodarone HCI), 360 mg/ (1.8 mg/mL) recalledNexterone | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | Mylan Institutional | Packaging Defects | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 900 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 450 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Amiodarone Hydrochloride Injection, USP, 150 mg recalledAmiodarone Hydrochloride | AuroMedics Pharma | Particulate Matter | Nationwide |