# FDA recall D-0573-2018

> **Baxter Healthcare Corporation** · Class I · drug recall initiated 2017-11-10.

## Product

Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag,  Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10

## 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

## Distribution

Nationwide within USA and Puerto Rico

## Key facts

- **Recall number:** D-0573-2018
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-10
- **Report date:** 2018-02-07
- **Termination date:** 2018-08-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0573-2018

## Citation

> AI Analytics. FDA recall D-0573-2018. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/D-0573-2018. Source: US FDA. Licensed CC0.

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