Drug recall
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia…
FDA recall event 88489 · Class II · Custopharm, Inc.
Key facts
| Event ID | 88489 |
|---|---|
| Recall numbers | D-0765-2021 |
| Recalling firm | Custopharm, Inc. |
| Product type | Drugs |
| Products | FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. |
| Initiation date | Jul 30, 2021 |
| Report date | Sep 1, 2021 |
| Termination date | Aug 8, 2022 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3010408760 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: