Baxter International Inc. announced that it is voluntarily recalling one lot of Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection due to the potential presence of particulate matter. The particulate matter may have entered the solution during the manufacturing process.
It was distributed between 6/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities.
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.
In a statement, Baxter said the extent and severity of harm depends on the size, number, and composition of the foreign material, and the patient’s underlying medical condition.
“In the absence of in-line filtration, these particles 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. To date, there have been no reports of adverse events associated with this issue.”
Nexerone is a prescription antiarrhythmic agent indicated for initiation of treatment and prophylaxis of 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 bag in which NEXTERONE is packaged.
The recall affects the following lot:
- Product Code: 2G3451
- Product Description: Nexterone (amiodarone HCl) Premixed Injection, 150 mg/100 mL
- Lot number: NC109925
- Expiration Date: 6/1/2019
- NDC: 43066-150-10