Product: niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.
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