FDAJuly 30, 2021drug
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
What to do
FDA enforcement status: Terminated
Brands named
custopharm
Recall history
No related federal recalls on record for this brand yet.
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