Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter

PUBLISHED: Jan 17, 2018
Relevant to: Critical Access Hospitals, Hospitals, Pharmacy

The US Food and Drug Administration (FDA) is informing health care professionals that Baxter International Inc. announced today it is expanding the recall of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter. The affected lots were distributed between 7/21/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities. The particulate matter may have entered the solution during the manufacturing process.

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. 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.

NEXTERONE 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.

Follow the link below for a list of affected lot numbers.

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Inform health care professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail user level. Recalled product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 888-229-0001, Monday through Friday, between 7 a.m. and 6 p.m. Central Time.

Customers with questions regarding this recall can contact Baxter Corporate Product Surveillance at 800-437-5176, Monday through Friday, between 8 a.m. and 5 p.m. Central Time. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program.

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