Class II · Moderate risk Ongoing
Azacitidine for Injection 100mg/Vial
Reason Lack of Sterility Assurance
Is Azacitidine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Azacitidine (9 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Azacitidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class III · Low risk Terminated
Azacitidine for Injection
Reason Subpotent Drug
Class III · Low risk Terminated
Azacitidine for Injection 100mg/vial Lyophilized Powder
Reason Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
Class III · Low risk Terminated
Azacitidine
Reason Failed stability specifications
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial For Subcutaneous and…
Reason cGMP deviations: Vials may not be sealed correctly affecting sterility.
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial
Reason CGMP Deviations
Class II · Moderate risk Terminated
Azacitidine for Injection 100 mg/vial
Reason CGMP Deviations
Class II · Moderate risk Terminated
Azacitidine 125 Mg / 5 Ml Sub-Q Syringe
Reason Lack of Assurance of Sterility
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