X-Gen Pharmaceuticals Inc.: Drug Recall
Recall #D-0434-2024 · 04/02/2024
Class III: Low Risk
Recall Details
- Recall Number
- D-0434-2024
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- X-Gen Pharmaceuticals Inc.
- Status
- Terminated
- Date Initiated
- 04/02/2024
- Location
- Horseheads, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1332 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'.
Product Description
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.
Distribution Pattern
Nationwide in the US
Other Recalls by X-Gen Pharmaceuticals Inc.
- Class III: Low Risk 04/02/2024
- Class II: Risk 03/19/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.