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'.
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 numbers, UPCs & expiration codes
Lot #: CIC1-23001 A, Exp. 08/30/2026
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0433-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 2, 2024
- FDA report date
- Apr 10, 2024
- Quantity
- 1283 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- X-Gen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0433-2024, exactly as published.
Show all FDA fields
- City
- Horseheads
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 94348
- Address
- 300 Daniel Zenker Dr
- Code information
- Lot #: CIC1-23001 A, Exp. 08/30/2026
- Postal code
- 14845-1014
- Report date
- Apr 10, 2024
- Product type
- Drugs
- Recall number
- D-0433-2024
- Classification
- Class III
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Product quantity
- 1283 vials
- Termination date
- Sep 30, 2025
- 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'.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Apr 2, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2024