FDA Drug Class III — Least Serious

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

Hazard

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

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 6004
Brand
Hospira Inc., A Pfizer Company
UPC
Lot: DP601, exp 10/2018

Units Affected

701 vials