# FDA recall D-096-2013

> **Hospira, Inc.** · Class II · drug recall initiated 2012-11-21.

## Product

Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01

## Reason for recall

Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-096-2013
- **Recalling firm:** Hospira, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-11-21
- **Report date:** 2012-12-26
- **Termination date:** 2014-06-03

- **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-096-2013

## Citation

> AI Analytics. FDA recall D-096-2013. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-096-2013. Source: US FDA. Licensed CC0.

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