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Nexterone (amiodarone HCI) recall

Baxter Healthcare Corporation recalled Nexterone (amiodarone HCI) on September 9, 2026 because of cGMP Deviations. It was sold nationwide.

Why it was recalled

CGMP Deviations

What's recalled

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.

Quantity: N/A

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Baxter Healthcare Corporation, Deerfield, IL
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide; Puerto Rico; and Chile.
Status
Ongoing
Recall number
D-0814-2026
Source
U.S. Food and Drug Administration

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