Antiarrhythmic Agent Recalled Due to Presence of Particulate Matter

Baxter announced a voluntary recall of Nexterone (amiodarone HCl) 150mg/100mL Premixed Injection due to the presence of particulate matter detected during a stability study.

Nexterone, an antiarrhythmic, is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

The affected products (Lot NC 109925; Product Code 2G3-451; Exp 6/1/2019) were distributed between 6/23/2017 and 10/2/2017 to wholesalers, distributors, and healthcare facilities. The Company stated the particulate matter may have entered the solution during the manufacturing process. The particulate appeared consistent with polyethylene, the main constituent of the film and ports used to make the bag that Nexterone is packaged in. 

If a solution containing sterile particulate matter is administered intravenously (IV), it may cause a range of adverse health consequences depending on the amount and composition of the foreign matter, as well as the patient’s underlying condition. Without in-line filtration, the particulate matter may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, pulmonary infarction, and systemic embolization.  

Baxter has not received any reports of adverse events associated with this issue to date. Any individual in possession of the recalled products should discontinue use and quarantine the product immediately. The affected products should be returned to Baxter for credit. 

For more information call (888) 229-0001 or visit FDA.gov.