# FDA recall D-0294-2015

> **Hospira Inc.** · Class II · drug recall initiated 2014-12-03.

## Product

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only,  25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

## Reason for recall

Lack of Assurance of Sterility; improperly crimped fliptop vials

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0294-2015
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-03
- **Report date:** 2014-12-17
- **Termination date:** 2015-10-02

- **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-0294-2015

## Citation

> AI Analytics. FDA recall D-0294-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0294-2015. Source: US FDA. Licensed CC0.

---

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