# FDA recall D-0044-2015

> **Hospira Inc.** · Class II · drug recall initiated 2014-10-01.

## Product

Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL  60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA  92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL  60045.

## Reason for recall

Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0044-2015
- **Recalling firm:** Hospira Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-10-01
- **Report date:** 2014-10-29
- **Termination date:** 2017-03-23

- **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-0044-2015

## Citation

> AI Analytics. FDA recall D-0044-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0044-2015. Source: US FDA. Licensed CC0.

---

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