# FDA recall D-395-2014

> **Hospira Inc.** · Class II · drug recall initiated 2013-10-11.

## Product

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.

## Reason for recall

Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-395-2014
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-11
- **Report date:** 2014-01-08
- **Termination date:** 2014-11-10

- **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-395-2014

## Citation

> AI Analytics. FDA recall D-395-2014. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-395-2014. Source: US FDA. Licensed CC0.

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