FDA recall D-1184-2018

Product

Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01

Reason for recall

Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2018-08-28

Report date

2018-09-19

Termination date

2020-06-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1184-2018