Class III
Terminated
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.
- Company
- X-Gen Pharmaceuticals Inc.
- Recall Initiated
- April 2, 2024
- Posted
- April 10, 2024
- Recall Number
- D-0433-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1283 vials
- Firm Location
- Horseheads, NY, United States
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'.
Distribution
Nationwide in the US
Lot / Code Info
Lot #: CIC1-23001 A, Exp. 08/30/2026
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