Custopharm, Inc. recalls FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceutical
Recalled September 1, 2021 · FDA recall D-0765-2021 · Custopharm
Hazard
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. · FDA Class II
Units
19,384 vials
Sold at
Distributed Nationwide in the USA
Description
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
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
Manufacturer(s)
Custopharm, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →