# FDA recall D-0336-2024

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2024-01-23.

## Product

Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015.  Made in Ireland.  NDC:  0338-0108-20

## Reason for recall

Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0336-2024
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-01-23
- **Report date:** 2024-02-28

- **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-0336-2024

## Citation

> AI Analytics. FDA recall D-0336-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0336-2024. Source: US FDA. Licensed CC0.

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