Drug 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
D-0765-2021
Product summary
- Firm
- Custopharm, Inc.
- Event
- Event 88489
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,384 vials
- Official record key
drug-enforcement:D-0765-2021
Official wording
Reason: Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Code information: Lot# 31327913C, Exp. Date 10/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility