Baxter Healthcare Corporation: Drug Recall

Recall Details

Recall Number

D-0146-2024

Classification

Class II

Product Type

Drug

Recalling Firm

Baxter Healthcare Corporation

Status

Completed

Date Initiated

11/14/2023

Location

Deerfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

6,022,675 vials

Reason for Recall

Failed pH Specifications

Product Description

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25

Distribution Pattern

Nationwide in the USA

Other Recalls by Baxter Healthcare Corporation

• Class II: Risk 12/22/2025
  Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
• Class II: Risk 11/28/2025
  Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
• Class II: Risk 10/28/2025
  Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
• Class II: Risk 09/17/2025
  Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.
• Class II: Risk 08/29/2025
  IV sets may leak.

View all recalls by Baxter Healthcare Corporation →