FDA Drug recall D-0765-2021
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U…
- FDA Drug
- Class II
- terminated
- Published 2021-09-01
On 2021-09-01 the FDA classified a Class II recall of FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U… by Custopharm, citing lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0765-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-30 |
| Published | 2021-09-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Custopharm |
| Distribution | US |
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
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Identifiers
| code_info | Lot# 31327913C, Exp. Date 10/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0765-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.