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 Dextrose, Bax...
Recall Summary Baxter Healthcare is recalling Nexterone (amiodarone HCI) 360 mg/200 mL injections in GALAXY containers due to manufacturing process deviations that don't meet regulatory standards. The affected product was distributed nationwide across the US, plus Puerto Rico and Chile. This is a Class II recall, meaning the product could cause adverse health effects, though serious injury or death is not expected.
- Recalling firm
- 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
- CGMP Deviations
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-08-06
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide; Puerto Rico; and Chile.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/cd2aced4-79e0-44f2-833c-0d94dd01beff