FDA recall D-0980-2017

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-07-06

Report date

2017-07-26

Termination date

2019-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0980-2017