RecallDepth
Class III Terminated

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

Company
Hospira Inc., A Pfizer Company
Recall Initiated
July 6, 2017
Posted
July 26, 2017
Recall Number
D-0980-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
701 vials
Firm Location
Lake Forest, IL, United States

Reason for Recall

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

Distribution

Nationwide

Lot / Code Info

Lot: DP601, exp 10/2018

More recalls by Hospira Inc., A Pfizer Company

View all recalls by this company →

Other recent Class III Drug recalls