# FDA recall D-0980-2017

> **Hospira Inc., A Pfizer Company** · Class III · drug recall initiated 2017-07-06.

## Product

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India,  Manufactured for:  Hospira, Inc, Lake Forest, IL 60045 ---  NDC  0409-1140-01

## Reason for recall

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0980-2017
- **Recalling firm:** Hospira Inc., A Pfizer Company
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-07-06
- **Report date:** 2017-07-26
- **Termination date:** 2019-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0980-2017

## Citation

> AI Analytics. FDA recall D-0980-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0980-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*