Drug product
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62
D-0575-2022
Product summary
- Event
- Event 89447
- Status
- Terminated
- Classification
- Class III
- Quantity
- 68061 vials
- Official record key
drug-enforcement:D-0575-2022
Official wording
Reason: Failed stability specifications
Code information: Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086, Exp 12/1/2023; H210130, Exp 1/1/2024; H210171, H210172, H210173, H210174, Exp 2/1/2024; H210196 & H210197, Exp 3/1/2024; H210283 & H210282, Exp 4/1/2024; H210382, H210381, H210419 & H210420, Exp 7/1/2024, H210445, Exp 8/1/2024.
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed stability specifications