X-Gen Pharmaceuticals Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 8 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0433-2024 | Class III | Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for | April 2, 2024 |
| D-0434-2024 | Class III | Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution | April 2, 2024 |
| D-0328-2021 | Class II | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN | March 19, 2021 |
| D-0519-2020 | Class III | Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Speci | October 11, 2019 |
| D-1084-2019 | Class III | Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured f | March 29, 2019 |
| D-1059-2017 | Class II | Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC | May 17, 2017 |
| D-0637-2017 | Class I | Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), package | February 8, 2017 |
| D-1444-2014 | Class III | Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured f | July 17, 2014 |