Status
Completed
Drug Enforcement D-0433-2024
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'.
Classification
Class III
Report Date
April 10, 2024
Termination Date
—
Product Information
- 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.
- Product quantity
- 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'.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Address
-
300 Daniel Zenker Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0433-2024
- Event ID
- 94348
- Recall initiation date
- April 2, 2024
- Center classification date
- April 4, 2024
- Code info
- Lot #: CIC1-23001 A, Exp. 08/30/2026
- More code info
- —