# FDA recall D-0146-2024

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2023-11-14.

## Product

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

## Reason for recall

Failed pH Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0146-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-11-14
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2024

## Citation

> AI Analytics. FDA recall D-0146-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0146-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
