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Par Sterile Products Recalls
4 recalls on record · May 17, 2017 to April 3, 2024 · Drugs
Recalls by year
17
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 3, 2024DrugsFDA
Par Sterile Products LLC recalls Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial,
Hazard: Presence of Particulate Matter.
January 24, 2024DrugsFDA
Par Sterile Products LLC recalls Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials
Hazard: Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
November 15, 2023DrugsFDA
PAR Sterile Products LLC recalls Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied i
Hazard: Crystallization; identified as Buprenorphine free base
May 17, 2017DrugsFDA
PAR Sterile Products LLC recalls Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials
Hazard: Crystallization: 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.