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]

Recall Number: D-0399-2025

Firm: American Regent, Inc.

Classification: Class II

Status: Ongoing

Report Date: 20250507

Initiation Date: 20250418

Termination Date:

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

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]