Product: niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Reason for recall: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Recall initiated: 20250418
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated