# FDA recall D-1167-2017

> **Pfizer Inc.** · Class II · drug recall initiated 2017-08-22.

## Product

HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)

## Reason for recall

Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

## Distribution

United States Nationwide (including Puerto Rico) and Singapore

## Key facts

- **Recall number:** D-1167-2017
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-22
- **Report date:** 2017-09-27
- **Termination date:** 2023-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1167-2017

## Citation

> AI Analytics. FDA recall D-1167-2017. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-1167-2017. Source: US FDA. Licensed CC0.

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