Baxter Extends Recall of Nexterone

January 17, 2018

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

On Jan. 16, 2018, Baxter announced it was expanding its voluntary recall of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection to include a second lot (NC109123). The first lot was recalled in November 2017 because of particulate matter found in the lot.

Baxter found the particulate matter during a stability study. The company states the particulate is consistent with polyethylene used to manufacture the product’s packaging. Baxter says that the particulates may have entered the solution during manufacturing.

Nexterone is an antiarrhythmic agent used “for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy,” according to Baxter. While there have not been any reports of adverse events in relation to the recalled product, administration of solution containing particulates may lead to vein irritation, allergic reactions, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and more, according to the company. 

The recalled lots were distributed between July 21, 2017 and Oct. 2, 2017 to wholesalers and distributors in the United States. The first lot has the expiration date of May 2019 and the second lot expires June 2019. Baxter is advising users to immediately stop use of existing inventory and quarantine the product. Adverse events may be report to FDA through its MedWatch program.

Source: FDA