# FDA recall D-0301-2015

> **Baxter Healthcare Corp.** · Class II · drug recall initiated 2014-11-25.

## Product

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04

## Reason for recall

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0301-2015
- **Recalling firm:** Baxter Healthcare Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-11-25
- **Report date:** 2014-12-24
- **Termination date:** 2015-10-28

- **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-0301-2015

## Citation

> AI Analytics. FDA recall D-0301-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0301-2015. Source: US FDA. Licensed CC0.

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