Custopharm, Inc.: Drug Recall
Recall #D-0765-2021 · 07/30/2021
Class II: Risk
Recall Details
- Recall Number
- D-0765-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Custopharm, Inc.
- Status
- Terminated
- Date Initiated
- 07/30/2021
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,384 vials
Reason for Recall
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Product Description
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
Distribution Pattern
Distributed Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.