# FDA recall D-1604-2014

> **Hospira Inc.** · Class II · drug recall initiated 2014-09-09.

## Product

Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10  Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32

## Reason for recall

Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1604-2014
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-09-09
- **Report date:** 2014-10-01
- **Termination date:** 2017-03-17

- **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-1604-2014

## Citation

> AI Analytics. FDA recall D-1604-2014. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1604-2014. Source: US FDA. Licensed CC0.

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