FDA Drug recall D-0575-2022
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd
- FDA Drug
- Class III
- terminated
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class III recall of Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd by Dr Reddy S Laboratories, citing failed stability specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0575-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-01-19 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
Reason
Failed stability specifications
Identifiers
| ndc | 43598-305-62 |
|---|---|
| code_info | Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086,…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0575-2022%22
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