Baxter International Inc., is recalling one lot of the heart medication Nexterone (amiodarone) after the company discovered particles floating in the solution during a stability study. The particulate was identified as consistent with polyethylene, the primary constituent of the film and ports used to manufacture the bag in which Nexterone is packaged. The matter is believed to have entered the solution during the manufacturing process.
Intravenous administration of a solution containing sterile particulate matter may cause adverse health consequences, the extent and severity of which depends on the size, number, and composition of the foreign matter and the patient’s underlying medical condition, the company said in a news release.
If in-line filtration is not used, the particles may cause local vein irrigation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary emboli, pulmonary infarction, and systemic embolization.
To date, Baxter has received no reports of injury associated with this issue.
Nexterone is a prescription antiarrhythmic agent that is used for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
The recall affects one lot of Nexterone (amiodarone HCl) Permixed Injection, 150mg/100mL, with the experiation date of 6/1/2019. Medical facilities with an existing inventory of the recalled product have been instructed to stop using and distributing it, and to quarantine the product immediately.
Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice