Class II recall: Baxter Healthcare Corporation: Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Cont
Baxter Healthcare Corporation has issued a Class II recall of Nexterone (amiodarone HCl), 360 mg/200 mL (1.8 mg/mL), supplied in GALAXY Single-Dose Containers, NDC 43066-360-20. The recall was initiated due to current good manufacturing practice (CGMP) deviations, according to the recall notice. The product is a sterile, nonpyrogenic, iso-osmotic solution in dextrose manufactured in the USA.
Most relevant for: patients receiving intravenous amiodarone for cardiac arrhythmia management who may have received affected Nexterone batches from this recall
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