# FDA recall D-0597-2018

> **Pfizer Inc.** · Class I · drug recall initiated 2018-02-07.

## Product

Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation.  Hospira, Inc., Lake forest, IL 60045 USA.  NDC:  0409-2634-01

## Reason for recall

Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0597-2018
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-07
- **Report date:** 2018-03-21
- **Termination date:** 2019-08-07

- **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-0597-2018

## Citation

> AI Analytics. FDA recall D-0597-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0597-2018. Source: US FDA. Licensed CC0.

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