FDA-Drug2021-09-01Class II
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
Custopharm, Inc.
Hazard
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Sold states
Distributed Nationwide in the USA
Affected count
19,384 vials
Manufactured in
2325 Camino Vida Roble, N/A, Carlsbad, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0765-2021Don't want to check this manually?
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