Carlsbad, CA, United States
Custopharm, Inc. recalls
1 recall recorded since 2018, most recently on 30 July 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 30 July 2021
- Terminated
- 8 August 2022
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.S.A, NDC 24201-237-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.