FLUDARABINE PHOSPHATE FOR INJECTION — Class II drug recall D-0765-2021
Terminated recall by Custopharm, Inc., reported 2021-09-01, distributed nationwide. Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitorin
| Recall number | D-0765-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Custopharm, Inc., Carlsbad, CA, United States |
| Recall initiated | 2021-07-30 |
| Classified | 2021-08-23 |
| Reported by FDA | 2021-09-01 |
| Terminated | 2022-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 19,384 vials |
| Reason classes | microbial contamination, sterility |
| NDC | 24201-0237-01 |
| Lot numbers | 31327913C |
| Expiration dates | 2022-10 |
Product
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
Reason for recall
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0765-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.