Reported Apr 10, 2024 · Terminated
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent,…
X-Gen Pharmaceuticals Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X-Gen Pharmaceuticals Inc. · 300 Daniel Zenker Dr · Horseheads, NY · 14845-1014
Is this the product you have?
- Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent
- After ReconstitutionFor direct intravenous injection or must be further diluted before intravenous infusion, Rx Only
- Manufactured forXGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01
- Lot codes and dates
Lot #: CIC2-23001 AExp. 11/30/2026
- Amount recalled
- 1332 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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'.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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