Recall: D-0399-2025

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, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]

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.