Medicine / D-0813-2026
U.S. Food and Drug AdministrationD-0813-2026
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…
Class II Distributed nationwide or U.S.-wide
Status: Ongoing
What was recalled
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.
Recalling firm
Baxter Healthcare Corporation
Reason for recall
CGMP Deviations
Where it went
US Nationwide; Puerto Rico; and Chile.
Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.