FDA Recall Terminated Historical recordClass III
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
- Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
- Published
- September 19, 2018
- Distribution
- Nationwide
