Multi event Drug Recall Enforcement Report Class III voluntary initiated by Dr. Reddy's Laboratories, Inc., originally initiated on 01-19-2022 for the 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 The product was recalled due to failed stability specifications. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0575-2022 | 01-19-2022 | 03-02-2022 | Class III | 68061 vials | 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 | Failed stability specifications | Terminated |
| D-0576-2022 | 01-19-2022 | 03-02-2022 | Class III | 18261 vials | Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62 | Failed stability specifications | Terminated |
| D-0577-2022 | 01-19-2022 | 03-02-2022 | Class III | 2,980 vials | 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 | Failed stability specifications | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 43598-305 | Azacitidine | Azacitidine | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | Dr. Reddy's Laboratories Inc. | Human Prescription Drug |
| 43598-465 | Azacitidine | Azacitidine | Injection, Powder, Lyophilized, For Solution | Intravenous; Subcutaneous | Dr. Reddy's Laboratories Inc. | Human Prescription Drug |
