Drug product
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62
D-0576-2022
Product summary
- Event
- Event 89447
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18261 vials
- Official record key
drug-enforcement:D-0576-2022
Official wording
Reason: Failed stability specifications
Code information: Lot#: H200107, Exp 8/1/2023; H200154, Exp 9/1/2023; H210020, Exp 11/1/2023; H210055, Exp 12/1/2023; H210129, Exp 1/1/2024, H210288, Exp 4/1/2024.
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed stability specifications