On November 14, 2017, Baxter International (BAX) announced a voluntary recall of one lot of its Nexterone (amiodarone HCl) 150 mg (milligram) or 100 mL (milliliter) Premixed Injection. The lot was distributed to wholesalers, distributors and healthcare facilities in the US between August 23, 2017, and October 2, 2017.
BAX stock witnessed a rise of ~0.08% the same day. The Health Care Select Sector SPDR Fund (XLV), which has ~1% of its total holdings in BAX, fell ~0.41% on November 14, 2017.
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 medication was added to Baxter’s portfolio through the acquisition of Prism Pharmaceuticals in 2011.
The particulate matter was found to be consistent with polyethylene, which is used in the manufacturing of the packaging bag of Nexterone.
Reason for the recall, health consequences
The reason for the recall was the potential presence of particulate matter that might have been introduced during the manufacturing process.
According to Baxter International, the Nexterone solution is administered intravenously, and so the particulate matter could cause adverse health issues, depending on the patient’s underlying condition, size, and the composition of the foreign material in the solution. Possible adverse effects include local vein irritation, aggravation of preexisting infections, inflammatory reactions, allergic reactions, pulmonary emboli, phlebitis, immune system dysfunction, pulmonary granulomas, pulmonary infarction, pulmonary dysfunction, and systemic embolization. However, no adverse events have been reported to date.