# FDA recall D-0004-2015

> **Baxter Healthcare Corp.** · Class II · drug recall initiated 2014-09-29.

## Product

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only,  Baxter USA, NDC 0338-1005-02.

## Reason for recall

Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.

## Distribution

Nationwide and Canada

## Key facts

- **Recall number:** D-0004-2015
- **Recalling firm:** Baxter Healthcare Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-09-29
- **Report date:** 2014-10-08
- **Termination date:** 2016-09-30

- **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-0004-2015

## Citation

> AI Analytics. FDA recall D-0004-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0004-2015. Source: US FDA. Licensed CC0.

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