# FDA recall D-0097-2023

> **Pfizer Inc.** · Class II · drug recall initiated 2022-12-29.

## Product

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

## Reason for recall

Lack of assurance of sterility: Bags have the potential to leak.

## Distribution

Nationwide in the USA.

## Key facts

- **Recall number:** D-0097-2023
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2022-12-29
- **Report date:** 2023-01-11

- **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-0097-2023

## Citation

> AI Analytics. FDA recall D-0097-2023. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-0097-2023. Source: US FDA. Licensed CC0.

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