The Recall Desk

FDA (Drugs) recall action 94348

X-Gen Pharmaceuticals Inc. recalled 2 products on 2024-04-10

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-04-10
Critical
0
Units
2,615

Why these products were recalled

Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2024-04-10

    Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error

    X-Gen Pharmaceuticals is recalling 1,283 vials of Cyclophosphamide for Injection due to a Package Insert error that lists concentration as '20 mg per vial' instead of '20 mg per mL'. No illnesses have been reported.

    Product
    Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-04-10

    Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error

    X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.

    Product
    Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJ
    Category
    Distribution
    0 states