Home / Recalls / American Regent, Inc. / D-0081-2025

D-0081-2025 Class II Ongoing

Recalled by American Regent, Inc. — Shirley, NY

Recall Details

Product Type
Drugs
Report Date
December 11, 2024
Initiation Date
November 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).

Reason for Recall

Presence of Particulate Matter: Potential for glass delamination from the vials.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.

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-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-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)