Recall: D-0398-2025

Class II - Potentially Harmful

Class IIClassification

2025-04-18Initiated

OngoingStatus

American Regent, Inc.Firm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.