Drug 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
D-1184-2018
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 80923
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,580 vials
- Official record key
drug-enforcement:D-1184-2018
Official wording
Reason: Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Code information: Lot: DP602, 10/2018
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Out of specification