Product: Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Reason for recall: Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Recall initiated: 20220722
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated