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Baxter Healthcare Corporation: Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextro

DrugsSource: FDA (drug) · Date: 2026-09-09

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Baxter Healthcare Corporation
Product
Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.
Reason / hazard
CGMP Deviations
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide; Puerto Rico; and Chile.
Recall initiated
2026-08-06
Code info
Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
99500
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