Hospira Inc., A Pfizer Company recalls Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma…

Recall date

July 6, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0980-2017

FDA classification

Class III

Brand / firm

Hospira Inc., A Pfizer Company

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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