One lot of amiodarone HCl (Nexterone; Baxter International, Inc.) premixed injection (150 mg/100 mL) has been recalled because particulate matter may have entered the solution during manufacturing, according a news release from the US Food and Drug Administration (FDA).
The lot was distributed to wholesalers and healthcare facilities in the United States between June 23 and October 2, 2017. Depending on a patient’s medical condition, the particles could aggravate preexisting infections and cause local vein irritation, inflammatory reactions, allergic reactions, phlebitis, pulmonary emboli, pulmonary infarction, pulmonary granulomas, pulmonary dysfunction, immune system dysfunction, and systemic embolization.
Amiodarone HCl is an antiarrhythmic agent used to treat and prevent frequently recurring ventricular fibrillation and unstable ventricular tachycardia in patients who do not respond to other therapies.
Healthcare professionals should immediately discontinue using amiodarone distributed from this lot. To report adverse reactions or any other issues with this product, please visit the FDA’s MedWatch Adverse Event Reporting program page.
Baxter issues a voluntary nationwide recall for one lot of Nexterone injection due to presence of particulate matter [news release]. Silver Spring, MD: US Food and Drug Administration; November 14, 2017. Accessed November 15, 2017.