Class II recall: Baxter Healthcare Corporation: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg
The FDA has classified a Class II recall of Baxter Healthcare's Cardene IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL, supplied in GALAXY Single-Dose Containers under NDC 43066-016-10. According to the recall notice, the action was initiated due to current good manufacturing practice (CGMP) deviations. The notice does not specify the nature of the deviations or additional details beyond the product identification and recall classification.
Most relevant for: patients receiving intravenous nicardipine for acute hypertension or acute coronary syndrome management
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