# FDA recall D-0863-2016

> **Baxter Healthcare Corp.** · Class I · drug recall initiated 2016-01-21.

## Product

Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

## Reason for recall

Presence of Particulate Matter: identified as a cloth fiber.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0863-2016
- **Recalling firm:** Baxter Healthcare Corp.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-21
- **Report date:** 2016-06-01
- **Termination date:** 2018-02-26

- **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-0863-2016

## Citation

> AI Analytics. FDA recall D-0863-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0863-2016. Source: US FDA. Licensed CC0.

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