# FDA recall D-1216-2015

> **Hospira Inc.** · Class I · drug recall initiated 2015-04-23.

## Product

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only.  HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

## Reason for recall

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

## Distribution

U.S. Nationwide including Guam.

## Key facts

- **Recall number:** D-1216-2015
- **Recalling firm:** Hospira Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-04-23
- **Report date:** 2015-07-15
- **Termination date:** 2016-01-26

- **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-1216-2015

## Citation

> AI Analytics. FDA recall D-1216-2015. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-1216-2015. Source: US FDA. Licensed CC0.

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