Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Recall Number: D-1334-2022
Firm: Teva Pharmaceuticals USA Inc
Classification: Class III
Status: Terminated
Report Date: 20220817
Initiation Date: 20220722
Termination Date: 20230412
Reason for Recall
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
Product Description
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56