Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Argatroban Injection Recalled by Hospira Inc., A Pfizer Company Due to Failed Impurities/Degradation Specifications; out of specification result for...

Date: July 6, 2017
Company: Hospira Inc., A Pfizer Company
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hospira Inc., A Pfizer Company directly.

Affected Products

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

Quantity: 701 vials

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hospira Inc., A Pfizer Company

Hospira Inc., A Pfizer Company has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report