Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx
Summary
The FDA issued a Class III for Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, S by X-Gen Pharmaceuticals Inc.. Reason: Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. T.
Details
Source
Drug Recall
External ID
D-0433-2024
Action Date
2024-04-10
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot #: CIC1-23001 A, Exp. 08/30/2026
Quantity Affected: 1283 vials
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-02
Company
Horseheads, NY
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
X-Gen Pharmaceuticals Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (X-Gen Pharmaceuticals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does X-Gen Pharmaceuticals Inc. have FDA actions?
X-Gen Pharmaceuticals Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0433-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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