Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solut...
FDA Recall #D-0434-2024 — Class III — April 2, 2024
Product Description
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 DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.
Reason for Recall
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'.
Recalling Firm
X-Gen Pharmaceuticals Inc. — Horseheads, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1332 vials
Distribution
Nationwide in the US
Code Information
Lot #: CIC2-23001 A, Exp. 11/30/2026
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated