# FDA recall D-1103-2023

> **Baxter Healthcare Corporation** · Class III · drug recall initiated 2023-08-14.

## Product

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

Nationwide in the U.S.A.

## Key facts

- **Recall number:** D-1103-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-08-14
- **Report date:** 2023-08-30

- **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-1103-2023

## Citation

> AI Analytics. FDA recall D-1103-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-1103-2023. Source: US FDA. Licensed CC0.

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