# FDA recall D-686-2013

> **Hospira Inc.** · Class II · drug recall initiated 2013-05-02.

## Product

Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.

## Reason for recall

Presence of Particulate Matter: visible particles were identified floating in the primary container.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-686-2013
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-02
- **Report date:** 2013-07-17
- **Termination date:** 2014-10-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-686-2013

## Citation

> AI Analytics. FDA recall D-686-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-686-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*