X-Gen Pharmaceuticals Inc. recalls Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent,…

Recall date

April 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0434-2024

FDA classification

Class III

Brand / firm

X-Gen Pharmaceuticals Inc.

Sold / distributed

Nationwide in the US

Why it was 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'.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.