# FDA recall D-0206-2017

> **Baxter Healthcare Corporation** · Class II · drug recall initiated 2016-12-06.

## Product

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.

## Reason for recall

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

## Distribution

United States, United Arab Emirates, and Colombia

## Key facts

- **Recall number:** D-0206-2017
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-06
- **Report date:** 2016-12-28
- **Termination date:** 2018-02-12

- **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-0206-2017

## Citation

> AI Analytics. FDA recall D-0206-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0206-2017. Source: US FDA. Licensed CC0.

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