The Recall Desk

Manufacturer

Custopharm, Inc.

1 recall in our database name Custopharm, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2021-09-01

Of the 1 recalls from Custopharm, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • SevereFDA (Drugs)·D-0765-2021·2021-09-01

    Fludarabine Phosphate Injection Recalled Due to Sterility Concern

    Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide