Drug 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
D-0980-2017
Product summary
- Event
- Event 77687
- Status
- Terminated
- Classification
- Class III
- Quantity
- 701 vials
- Official record key
drug-enforcement:D-0980-2017
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Code information: Lot: DP601, exp 10/2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification