# FDA recall D-0384-2021

> **Pfizer Inc.** · Class II · drug recall initiated 2021-05-03.

## Product

Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

## Reason for recall

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0384-2021
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-05-03
- **Report date:** 2021-05-26
- **Termination date:** 2023-07-29

- **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-0384-2021

## Citation

> AI Analytics. FDA recall D-0384-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0384-2021. Source: US FDA. Licensed CC0.

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