FDAFDA · Food and drugs·Recall number D-0434-2024
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.
Published April 10, 2024 · Recall initiated: April 2, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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'.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Distributor
- Nationwide in the US
- Lot
- Lot #: CIC2-23001 A, Exp. 11/30/2026
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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