FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx O Supply Disruption — Custopharm, Inc. (Moderate Ri
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx O Supply Disruption — Custopharm, Inc. (Moderate Ri is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx O; Manufacturer: Custo
| Drug name | FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx O |
|---|---|
| Manufacturer | Custopharm, Inc. |
| Recall/Disruption reason | Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in asept |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0765-2021 |
| Initiation date | 20210730 |
| Quantity affected | 19,384 vials |
| Dosage form | Drugs |
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