CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 m…
Official notice from a government agency or its published feed.
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: CGMP Deviations
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.
Reason: CGMP Deviations
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.
Hazard: CGMP Deviations
View the FDA enforcement report ↗ ← All reports