Drug product
Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60
D-0577-2022
Product summary
- Event
- Event 89447
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,980 vials
- Official record key
drug-enforcement:D-0577-2022
Official wording
Reason: Failed stability specifications
Code information: Lot # H210233, Exp 3/1/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed stability specifications