Class II · Moderate risk Ongoing
Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only…
Reason Lack of Sterility Assurance
Is Azacitidine recalled?
9 FDA recalls mention Azacitidine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Azacitidine.
Class III · Low risk Terminated
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals…
Reason Subpotent Drug
Class III · Low risk Terminated
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint…
Reason Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class III · Low risk Terminated
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…
Reason Failed stability specifications
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare…
Reason cGMP deviations: Vials may not be sealed correctly affecting sterility.
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent…
Reason CGMP Deviations
Class II · Moderate risk Terminated
AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only…
Reason Lack of Assurance of Sterility
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