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 L
Recalled July 26, 2017 · FDA recall D-0980-2017 · Hospira Inc., A Pfizer
Hazard
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point · FDA Class III
Units
701 vials
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
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
Manufacturer(s)
Hospira Inc., A Pfizer Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →