Home / Recalls / American Regent, Inc. / D-0503-2024

D-0503-2024 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
May 29, 2024
Initiation Date
May 14, 2024
Termination Date
December 23, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,136 cartons (10 vials in each carton)

Product Description

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10

Reason for Recall

Lack of Assurance of Sterility.

Distribution Pattern

UT only

Code Information

Lot #: 23087N0C0, Exp. Date 11/2024

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-0398-2025 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-0507-2024 Class II — Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multipl (May 13, 2024)