American Regent, Inc. recalls niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc
Recalled May 7, 2025 · FDA recall D-0399-2025 · 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
7,249 (cartons of 10 x 10 mL 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, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Manufacturer(s)
American Regent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →