Home / Recalls / Baxter Healthcare Corporation / D-1103-2023

D-1103-2023 Class III

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Drugs
Report Date
August 30, 2023
Initiation Date
August 14, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,502 vials

Product Description

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.

Reason for Recall

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Distribution Pattern

Nationwide in the U.S.A.

Code Information

Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025

Other recalls by Baxter Healthcare Corporation

  • Z-1573-2026 Class II — Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS (February 18, 2026)
  • Z-1637-2026 Class I — Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. (February 18, 2026)
  • Z-1368-2026 Class II — Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570 (January 13, 2026)
  • D-0296-2026 Class II — Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxte (December 22, 2025)
  • Z-1121-2026 Class II — SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 (November 28, 2025)
  • Z-0847-2026 Class II — Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product r (October 28, 2025)
  • Z-0233-2026 Class II — Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Pl (September 17, 2025)
  • Z-0203-2026 Class II — CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and C (August 29, 2025)
  • Z-0195-2026 Class II — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CL (August 29, 2025)
  • Z-0190-2026 Class II — CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drop (August 29, 2025)