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# Baxter Expands Nexterone Recall Due to Particulate Matter
- URL: https://www.fdaweb.com/baxter-expands-nexterone-recall-due-to-particulate-matter/
- Published: 2018-01-17T12:00:00.000Z
- Updated: 2026-09-14T23:14:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140518

Baxter International has expanded its 11/2017 recall of one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection to include a second lot due to the potential presence of particulate matter. Affected lots were distributed between 7/21/2017 and 10/2/2017 in the U.S. The company says the particulate matter may have entered the solution during the manufacturing process, according to a [recall notice](https://www.fda.gov/Safety/Recalls/ucm592678.htm?utm%5Fcampaign=Baxter%20Expands%20Voluntary%20Nationwide%20Recall%20to%20Include%20Second%20Lot%20of%20Nexterone%20Injection&utm%5Fmedium=email&utm%5Fsource=Eloqua).  

Nexterone is a prescription antiarrhythmic agent indicated for treating frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. The particulate matter was identified by Baxter during a stability study, and was consistent with polyethylene, the primary constituent of the film and ports used to manufacture the product packaging bag, the notice says.