Par Sterile Products recalls
FDA enforcement reports naming Par Sterile Products LLC as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 1
- Most recent report
- Apr 3, 2024
- Apr 3, 2024Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion…Drug · Par Sterile Products LLCPresence of Particulate Matter.Class I
- Jan 24, 2024Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0Drug · Par Sterile Products LLCSuperpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.Class II
- Nov 15, 2023Buprenorphine HCl, Injection, 0Drug · PAR Sterile Products LLCCrystallization; identified as Buprenorphine free baseClass II
- May 17, 2017Buprenorphine HCI Injection, 0Drug · PAR Sterile Products LLCCrystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.Class II