
Baxter Recalls NEXTERONE
The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.
On Nov. 14, 2017, Baxter issued a
Baxter identified the particulates, which are consistent with polyethylene, during a stability study. Polyethylene is a primary constituent of the film and ports of the packaging of the product. While there have been no reports of adverse events as of the date of the recall, the company is stating that use and distribution of the product should be stopped. According to the company, intravenous administration of product that contains particulate matter may cause harm including 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.
NEXTERONE, a prescription antiarrhythmic agent, is used to treat and prevent recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients resistant to other therapy.
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