D-1184-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 19, 2018
- Initiation Date
- August 28, 2018
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,580 vials
Product Description
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 Pattern
Nationwide USA
Code Information
Lot: DP602, 10/2018