Baxter Recalls NEXTERONE

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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 voluntary nationwide recall of one lot of NEXTERONE 150 mg/100 mL Premixed Injection because particulate matter was found in the product. The recalled lot, NC109925, was distributed in the United States to wholesalers, distributors, and healthcare facilities from June 23, 2017 to October 2, 2017. The company stated in a press release that the particulate matter may have entered the solution during manufacturing.

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.


Source: FDA