# FDA recall D-0765-2021

> **Custopharm, Inc.** · Class II · drug recall initiated 2021-07-30.

## 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.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0765-2021
- **Recalling firm:** Custopharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-30
- **Report date:** 2021-09-01
- **Termination date:** 2022-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0765-2021

## Citation

> AI Analytics. FDA recall D-0765-2021. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-0765-2021. Source: US FDA. Licensed CC0.

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