American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc
Recalled May 7, 2025 · FDA recall D-0398-2025 · American Regent
Hazard
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. · FDA Class II
Units
29,777 (cartons of 10 x 10mL vials)
Sold at
Nationwide in the USA
Description
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
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.
Manufacturer(s)
American Regent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →