American Regent, Inc.: Drug Recall

Recall #D-0399-2025 · 04/18/2025

Class II: Risk

Recall Details

Recall Number: D-0399-2025
Classification: Class II
Product Type: Drug
Recalling Firm: American Regent, Inc.
Status: Ongoing
Date Initiated: 04/18/2025
Location: New Albany, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,249 (cartons of 10 x 10 mL vials)

Reason for Recall

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

Product Description

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]

Distribution Pattern

Nationwide in the USA

Other Recalls by American Regent, Inc.

Class II: Risk 04/18/2025

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 05/14/2024

Lack of Assurance of Sterility.

View all recalls by American Regent, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.