Custopharm recalls

FDA enforcement reports naming Custopharm, Inc. as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Sep 1, 2021

Severity

Sep 1, 2021FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only,…Drug · Custopharm, Inc.Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.Class II