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Baxter Healthcare Corporation: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manu

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
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.
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 # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
99500
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