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Baxter Healthcare Corporation: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx on

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
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
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 # NC188654, Exp Date: 08/31/2027; Lot # NC188821, Exp Date: 09/30/2027; Lot # NC193658, NC193702, Exp Date: 01/31/2028.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
99500
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