(Credit: Baxter International Inc. via FDA)
Baxter expands voluntary nationwide recall to include second lot of Nexterone Injection due to presence of particulate matter.
Following the issuance of a voluntary recall dated November 10, 2017 of one lot of Nexterone (amiodarone HCl) 150 mg/100 mL premixed injection, Baxter International Inc. announced it is expanding the recall 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.
Click here to read the current MedWatch safety alert press release concerning the expanded recall. Click here for the original recall news report in Pharmaceutical Processing.
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