# FDA recall D-0380-2015

> **Baxter Healthcare Corp.** · Class II · drug recall initiated 2014-12-23.

## Product

Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015 USA, NDC 0338-6046-48, Product Code 2J1446.

## Reason for recall

Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.

## Distribution

Nationwide, United Arab Emirates, and Columbia

## Key facts

- **Recall number:** D-0380-2015
- **Recalling firm:** Baxter Healthcare Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-23
- **Report date:** 2015-02-04
- **Termination date:** 2016-04-21

- **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-0380-2015

## Citation

> AI Analytics. FDA recall D-0380-2015. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0380-2015. Source: US FDA. Licensed CC0.

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