# FDA recall D-0003-2023

> **Pfizer Inc.** · Class II · drug recall initiated 2022-09-27.

## Product

Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only,  Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)

## Reason for recall

Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.

## Distribution

Distributed in the United States and Puerto Rico.

## Key facts

- **Recall number:** D-0003-2023
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-27
- **Report date:** 2022-10-12
- **Termination date:** 2024-08-21

- **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-0003-2023

## Citation

> AI Analytics. FDA recall D-0003-2023. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0003-2023. Source: US FDA. Licensed CC0.

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