D-0576-2022 Class III Terminated
FDA drug recall D-0576-2022 was initiated by Dr. Reddy's Laboratories, Inc. on Jan 19, 2022 and is designated Class III. Reason for recall: Failed stability specifications The recall status is terminated (terminated Dec 13, 2022). Affected quantity: 18261 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 2, 2022
- Initiation Date
- Jan 19, 2022
- Termination Date
- Dec 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18261 vials
Product Description
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62
Reason for Recall
Failed stability specifications
Distribution Pattern
USA Nationwide
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0576-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026