Home / Recalls / American Regent, Inc. / D-0398-2025

D-0398-2025 Class II Ongoing

Recalled by American Regent, Inc. — New Albany, OH

Recall Details

Product Type
Drugs
Report Date
May 7, 2025
Initiation Date
April 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,777 (cartons of 10 x 10mL vials)

Product Description

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 for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026

Other recalls by American Regent, Inc.

  • D-0399-2025 Class II — niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single (April 18, 2025)
  • D-0080-2025 Class II — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), (November 11, 2024)
  • D-0082-2025 Class II — Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), (November 11, 2024)
  • D-0081-2025 Class II — Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL) (November 11, 2024)
  • D-0503-2024 Class II — niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Si (May 14, 2024)
  • D-0507-2024 Class II — Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multipl (May 13, 2024)