Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FLUDARABINE PHOSPHATE FOR INJECTION Recalled by Custopharm, Inc. Due to Lack of Assurance of Sterility: the manufacturing firm...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Custopharm, Inc. directly.
Affected 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
Quantity: 19,384 vials
Why Was This Recalled?
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Custopharm, Inc.
Custopharm, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report