# FDA recall D-1184-2018

> **Pfizer Inc.** · Class III · drug recall initiated 2018-08-28.

## Product

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA.  NDC:  0409-1140-01

## Reason for recall

Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1184-2018
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2018-09-19
- **Termination date:** 2020-06-26

- **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-1184-2018

## Citation

> AI Analytics. FDA recall D-1184-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1184-2018. Source: US FDA. Licensed CC0.

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