FLUDARABINE PHOSPHATE FOR INJECTION recalled over sterility concerns

Recall date

July 30, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Custopharm, Inc. recalls FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals…

Recall number

D-0765-2021

FDA classification

Class II

Brand / firm

Custopharm, Inc.

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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