Par Sterile Products LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 4 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0429-2024 | Class I | Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL | March 4, 2024 |
| D-0232-2024 | Class II | Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x | January 11, 2024 |
| D-0087-2024 | Class II | Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Do | November 9, 2021 |
| D-0698-2017 | Class II | Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x | April 28, 2017 |