NICARDIPINE HYDROCHLORIDE

Wed May 07 2025

Summary

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Drug	Manufacturer	Distribution Pattern	Number of Affected Units
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.	Civica, Inc.	Nationwide in the USA	29,777 (cartons of 10 x 10mL vials)
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]	American Regent, Inc.	Nationwide in the USA	7,249 (cartons of 10 x 10 mL vials)