FDAFDA · Food and drugs·Recall number D-0765-2021
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
Published September 1, 2021 · Recall initiated: July 30, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Custopharm, Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot# 31327913C, Exp. Date 10/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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