Baxter Healthcare Corporation — Class II: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL
Baxter Healthcare Corporation has initiated a Class II recall for Cardene IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL, due to CGMP deviations. The recall remains ongoing and affects products distributed in GALAXY Single-Dose Containers (NDC 43066-016-10).
This recall affects Baxter Healthcare Corporation and healthcare facilities utilizing Cardene IV GALAXY containers, as well as personnel in quality assurance, sterile manufacturing, and hospital procurement.
A Class II designation suggests that exposure to the non-compliant product may cause temporary or medically reversible adverse health consequences, though the source does not specify the exact nature of the CGMP deviation. Regulatory teams should interpret this as a potential failure in sterile manufacturing standards or documentation controls at the Deerfield-linked facility. The 'ongoing' status implies that reconciliation and root cause analysis may still be in progress.
QA and Supply Chain teams should immediately verify if affected NDC 43066-016-10 lots are in inventory. Manufacturing teams should investigate if the cited CGMP deviations stem from specific GALAXY container fill-finish processes or broader systemic facility issues.
Class II. Reason: CGMP Deviations. 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.. Firm: Baxter Healthcare Corporation (Deerfield IL United States). Status: Ongoing.
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