X-Gen Pharmaceuticals Inc. recalls Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx
Recalled April 10, 2024 · FDA recall D-0433-2024 · X-Gen Pharmaceuticals
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'. · FDA Class III
Units
1283 vials
Sold at
Nationwide in the US
Description
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'.
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.
Manufacturer(s)
X-Gen Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →